<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01729923</url>
  </required_header>
  <id_info>
    <org_study_id>7707</org_study_id>
    <secondary_id>NCI-2012-02137</secondary_id>
    <secondary_id>7707</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT01729923</nct_id>
  </id_info>
  <brief_title>A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer</brief_title>
  <acronym>ADAPT</acronym>
  <official_title>A Phase II Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well capecitabine and celecoxib with or without radiation&#xD;
      therapy works in treating patients with colorectal cancer that is newly diagnosed or has been&#xD;
      previously treated with fluorouracil, and has spread to other parts of the body (metastatic).&#xD;
      Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth&#xD;
      of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may&#xD;
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.&#xD;
      Radiation therapy uses high-energy x-rays to kill tumor cells. Giving capecitabine and&#xD;
      celecoxib together with radiation therapy may kill more tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the rate of complete response 2 years following the initiation of first line&#xD;
      5-FU (fluorouracil) based chemotherapy in patients with initially unresected metastatic&#xD;
      colorectal cancer who are then treated on the activating cancer stem cells (CSCs) from&#xD;
      dormancy and priming them for subsequent targeting (ADAPT) protocol.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine overall survival, relapse free survival (if complete response [CR]) based on&#xD;
      intent to treat (ITT) analysis.&#xD;
&#xD;
      II. To determine quality of life while on ADAPT therapy.&#xD;
&#xD;
      III. To determine the effects of v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras)&#xD;
      mutation status, resection and radiation on response to ADAPT therapy.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance&#xD;
      ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or&#xD;
      upon achievement of resectable disease after radiation therapy.&#xD;
&#xD;
      RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive&#xD;
      capecitabine orally (PO) twice daily (BID) and celecoxib PO BID 5 days per week during&#xD;
      radiation.&#xD;
&#xD;
      ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21.&#xD;
      Courses repeat every 21 days for up to 3 years in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 1 year,&#xD;
      every 4 months for 2 years, and then every 6 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding ended&#xD;
  </why_stopped>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 6, 2016</completion_date>
  <primary_completion_date type="Actual">September 6, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</measure>
    <time_frame>3 years</time_frame>
    <description>Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion</measure>
    <time_frame>Serial measures at 9 week intervals up to 5 years</time_frame>
    <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy</measure>
    <time_frame>Serial measures at 9 week intervals up to 5 years</time_frame>
    <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K-ras Mutation Status</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Until death or last reported survival, up to 5 years</time_frame>
    <description>Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse Free Survival in Patients Achieving CR</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Recurrent Colon Carcinoma</condition>
  <condition>Recurrent Rectal Carcinoma</condition>
  <condition>Stage IVA Colon Cancer</condition>
  <condition>Stage IVA Rectal Cancer</condition>
  <condition>Stage IVB Colon Cancer</condition>
  <condition>Stage IVB Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.&#xD;
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.&#xD;
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>Ro 09-1978/000</other_name>
    <other_name>Xeloda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-</other_name>
    <other_name>Celebrex</other_name>
    <other_name>SC-58635</other_name>
    <other_name>YM 177</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy</intervention_name>
    <description>Undergo IMRT</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>IMRT</other_name>
    <other_name>Intensity Modulated RT</other_name>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>Cancer Radiotherapy</other_name>
    <other_name>Irradiate</other_name>
    <other_name>Irradiated</other_name>
    <other_name>Irradiation</other_name>
    <other_name>RADIATION</other_name>
    <other_name>Radiotherapeutics</other_name>
    <other_name>Radiotherapy</other_name>
    <other_name>RT</other_name>
    <other_name>Therapy, Radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Radiosurgery</intervention_name>
    <description>Undergo stereotactic radiosurgery</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
    <other_name>Stereotactic External Beam Irradiation</other_name>
    <other_name>stereotactic external-beam radiation therapy</other_name>
    <other_name>Stereotactic Radiation Therapy</other_name>
    <other_name>Stereotactic Radiotherapy</other_name>
    <other_name>stereotaxic radiation therapy</other_name>
    <other_name>stereotaxic radiosurgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic Conventional Surgery</intervention_name>
    <description>Undergo surgical resection</description>
    <arm_group_label>Treatment (capecitabine, celecoxib, radiation therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed colorectal cancer&#xD;
&#xD;
          -  Evaluable or measurable radiographic evidence of colorectal cancer&#xD;
&#xD;
          -  Patients with unresected metastases from colorectal cancer; patients may be either&#xD;
             untreated with chemotherapy or currently receiving first-line 5-FU based chemotherapy&#xD;
             (folinic acid-fluorouracil-irinotecan hydrochloride [FOLFIRI], capecitabine-irinotecan&#xD;
             hydrochloride [CAPIRI], fluorouracil-leucovorin calcium-oxaliplatin [FOLFOX], or&#xD;
             capecitabine-oxaliplatin [CAPOX] with or without bevacizumab) within 10 months of&#xD;
             beginning ADAPT therapy with at least stable disease radiographically; patients who&#xD;
             received prior adjuvant chemotherapy with 5-FU, capecitabine, or FOLFOX are eligible&#xD;
             if adjuvant therapy was completed greater than 6 months ago&#xD;
&#xD;
          -  History of histological confirmation for recurrent disease, or if recurrent disease is&#xD;
             not readily accessible to biopsy, must have two consecutive carcinoembryonic antigen&#xD;
             (CEA) or cancer antigen (CA) 19-9 increases, or positron emission tomography (PET)&#xD;
             avidity&#xD;
&#xD;
          -  Men and women from all ethnic and racial groups&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 2&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x the institutional upper-normal limit (IUNL)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])&#xD;
             and/or alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =&lt;&#xD;
             2.5 x IUNL&#xD;
&#xD;
          -  Alkaline phosphatase =&lt; 2.5 x IUNL&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/uL&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,000/uL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/uL&#xD;
&#xD;
          -  Women of childbearing potential and all men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control) prior to beginning ADAPT therapy and for&#xD;
             the duration of study participation&#xD;
&#xD;
          -  Negative urine pregnancy test for women of childbearing potential&#xD;
&#xD;
          -  Must have the ability to understand and the willingness to provide a written informed&#xD;
             consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergies to sulfonamide, aspirin, any nonsteroidal anti-inflammatory drugs&#xD;
             (NSAIDS), 5-FU or celecoxib&#xD;
&#xD;
          -  Prior 5-FU-based adjuvant chemotherapy less than 6 months prior to beginning ADAPT&#xD;
             therapy and any residual neuropathy &gt; grade 2&#xD;
&#xD;
          -  Any regular use of cyclooxygenase-2 (COX-2) inhibitors as defined by 2-3 times per&#xD;
             week&#xD;
&#xD;
          -  Use of aspirin is NOT an exclusion criterion as long as the daily dose does not exceed&#xD;
             325 mg daily; initiation of ADAPT therapy requires patient to discontinue aspirin for&#xD;
             18 months&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  History of significant neurologic or psychiatric disorders, including dementia or&#xD;
             seizures that would impede consent, treatment, or follow up&#xD;
&#xD;
          -  Any serious illness or medical condition that could affect participation on trial&#xD;
&#xD;
          -  Any uncontrolled congestive heart failure New York Heart Association class III or IV&#xD;
&#xD;
          -  Any uncontrolled hypertension, arrhythmia, or active angina pectoris&#xD;
&#xD;
          -  Any history of major myocardial infarction, stroke or transient ischemic attack (TIA);&#xD;
             minor acute myocardial infarction (AMI) and patients who have had cardiac bypass free&#xD;
             of symptoms for at least 2 years may be eligible at the discretion of the study chair&#xD;
&#xD;
          -  Serious uncontrolled active infection&#xD;
&#xD;
          -  Patients with creatinine clearance: &lt; 50 mL/min are excluded from this protocol;&#xD;
             capecitabine is contraindicated in severe renal impairment (clearance &lt; 40 mL/min)&#xD;
&#xD;
          -  Inability to swallow oral medications or any medical conditions that may affect&#xD;
             intestinal absorption of the study agent or inability to comply with oral medication&#xD;
&#xD;
          -  History of active peptic ulcer disease or major upper gastrointestinal (GI) bleed &lt; 12&#xD;
             months; history of GI bleeding from the colorectal cancer primary is not an exclusion&#xD;
             criterion&#xD;
&#xD;
          -  Use of warfarin is not allowed; patient is recommended to switch to low molecular&#xD;
             weight heparin (LMWH) before participating in this study&#xD;
&#xD;
          -  Patients with any history of brain or bone metastasis or who have developed&#xD;
             progressive disease on first line 5-FU based therapy&#xD;
&#xD;
          -  Current use of systemic steroid medication&#xD;
&#xD;
          -  Patients with an obstructive synchronous colorectal tumor requiring up-front surgery&#xD;
             or chemoradiation&#xD;
&#xD;
          -  Patients with partial or complete bowel obstruction due to abdominal carcinomatosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacey Cohen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>September 5, 2017</results_first_submitted>
  <results_first_submitted_qc>October 24, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2017</results_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Stacey Cohen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Benzenesulfonamide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was activated on March 30, 2013 and terminated on August 12, 2016 due to lack of funding and prior to reaching its enrollment goal. A total 27 participants were accrued.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Capecitabine, Celecoxib, Radiation Therapy)</title>
          <description>Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.&#xD;
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.&#xD;
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.&#xD;
Capecitabine: Given PO&#xD;
Celecoxib: Given PO&#xD;
Intensity-Modulated Radiation Therapy: Undergo IMRT&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Radiation Therapy: Undergo radiation therapy&#xD;
Stereotactic Radiosurgery: Undergo stereotactic radiosurgery&#xD;
Therapeutic Conventional Surgery: Undergo surgical resection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Capecitabine, Celecoxib, Radiation Therapy)</title>
          <description>Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.&#xD;
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.&#xD;
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.&#xD;
Capecitabine: Given PO&#xD;
Celecoxib: Given PO&#xD;
Intensity-Modulated Radiation Therapy: Undergo IMRT&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Radiation Therapy: Undergo radiation therapy&#xD;
Stereotactic Radiosurgery: Undergo stereotactic radiosurgery&#xD;
Therapeutic Conventional Surgery: Undergo surgical resection</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" lower_limit="30" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</title>
        <description>Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</title>
          <description>Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion</title>
        <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
        <time_frame>Serial measures at 9 week intervals up to 5 years</time_frame>
        <population>All patients who had RECIST measures at baseline and at least one other time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion</title>
          <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
          <population>All patients who had RECIST measures at baseline and at least one other time point.</population>
          <units>percentage of baseline lesion size</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17" lower_limit="-100" upper_limit="75.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy</title>
        <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
        <time_frame>Serial measures at 9 week intervals up to 5 years</time_frame>
        <population>Patients who had RECIST measurements at baseline and at least one subsequent occasion and did not have surgery or radiation therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy</title>
          <description>RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.</description>
          <population>Patients who had RECIST measurements at baseline and at least one subsequent occasion and did not have surgery or radiation therapy</population>
          <units>percentage of baseline lesion size</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="-31.2" upper_limit="75.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>K-ras Mutation Status</title>
        <description>The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>K-ras mutation status was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>K-ras Mutation Status</title>
          <description>The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.</description>
          <population>K-ras mutation status was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.</description>
        <time_frame>Until death or last reported survival, up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="2" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)</title>
        <description>Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>We have been unable to confirmation that the original Principal Investigator secured the appropriate permission to use this instrument. Therefore, we are unable to use the data.</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)</title>
          <description>Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.</description>
          <population>We have been unable to confirmation that the original Principal Investigator secured the appropriate permission to use this instrument. Therefore, we are unable to use the data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relapse Free Survival in Patients Achieving CR</title>
        <description>Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Measure Description: Inclusive of subject still alive at time of last reporting Time Frame: Until last reported survival Study terminated; data not further analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine and Celecoxib</title>
            <description>Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Relapse Free Survival in Patients Achieving CR</title>
          <description>Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.</description>
          <population>Measure Description: Inclusive of subject still alive at time of last reporting Time Frame: Until last reported survival Study terminated; data not further analyzed</population>
          <units>months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <desc>The adverse event recording period will start on the first day of study treatment and end 30 days after last protocol required treatment is administered. Only grade 2 and higher AEs will be recorded with the exception of any AE that requires a dose reduction or treatment interruption.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Capecitabine, Celecoxib, Radiation Therapy)</title>
          <description>Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.&#xD;
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.&#xD;
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.&#xD;
Capecitabine: Given PO&#xD;
Celecoxib: Given PO&#xD;
Intensity-Modulated Radiation Therapy: Undergo IMRT&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Radiation Therapy: Undergo radiation therapy&#xD;
Stereotactic Radiosurgery: Undergo stereotactic radiosurgery&#xD;
Therapeutic Conventional Surgery: Undergo surgical resection</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 3.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nonoliguric Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE 3.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Post-Operative Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus (autoimmune reaction)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hand/Foot Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Stacey Cohen, Principal Investigator</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-606-6658</phone>
      <email>shiovitz@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729923
org study id: 7707
secondary id: NCI-2012-02137
secondary id: 7707
secondary id: P30CA015704
nct id: NCT01729923
lead sponsor: 
collaborator: 
has dmc: No
This phase II trial studies how well capecitabine and celecoxib with or without radiation
      therapy works in treating patients with colorectal cancer that is newly diagnosed or has been
      previously treated with fluorouracil, and has spread to other parts of the body (metastatic).
      Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
      Radiation therapy uses high-energy x-rays to kill tumor cells. Giving capecitabine and
      celecoxib together with radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:

      I. To determine the rate of complete response 2 years following the initiation of first line
      5-FU (fluorouracil) based chemotherapy in patients with initially unresected metastatic
      colorectal cancer who are then treated on the activating cancer stem cells (CSCs) from
      dormancy and priming them for subsequent targeting (ADAPT) protocol.

      SECONDARY OBJECTIVES:

      I. To determine overall survival, relapse free survival (if complete response [CR]) based on
      intent to treat (ITT) analysis.

      II. To determine quality of life while on ADAPT therapy.

      III. To determine the effects of v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras)
      mutation status, resection and radiation on response to ADAPT therapy.

      OUTLINE:

      Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance
      ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or
      upon achievement of resectable disease after radiation therapy.

      RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive
      capecitabine orally (PO) twice daily (BID) and celecoxib PO BID 5 days per week during
      radiation.

      ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21.
      Courses repeat every 21 days for up to 3 years in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 1 year,
      every 4 months for 2 years, and then every 6 months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
time frame: 3 years
description: Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.
measure: Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion
time frame: Serial measures at 9 week intervals up to 5 years
description: RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.
measure: Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy
time frame: Serial measures at 9 week intervals up to 5 years
description: RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.
measure: K-ras Mutation Status
time frame: Up to 5 years
description: The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.
measure: Overall Survival
time frame: Until death or last reported survival, up to 5 years
description: Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.
measure: Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)
time frame: Up to 5 years
description: Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.
measure: Relapse Free Survival in Patients Achieving CR
time frame: Up to 5 years
description: Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
arm group type: Experimental
description: Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.
RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.
ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Capecitabine
description: Given PO
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: Ro 09-1978/000
other name: Xeloda
intervention type: Drug
intervention name: Celecoxib
description: Given PO
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
other name: Celebrex
other name: SC-58635
other name: YM 177
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy
description: Undergo IMRT
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: IMRT
other name: Intensity Modulated RT
other name: Intensity-Modulated Radiotherapy
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: Quality of Life Assessment
intervention type: Radiation
intervention name: Radiation Therapy
description: Undergo radiation therapy
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: Cancer Radiotherapy
other name: Irradiate
other name: Irradiated
other name: Irradiation
other name: RADIATION
other name: Radiotherapeutics
other name: Radiotherapy
other name: RT
other name: Therapy, Radiation
intervention type: Radiation
intervention name: Stereotactic Radiosurgery
description: Undergo stereotactic radiosurgery
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
other name: Stereotactic External Beam Irradiation
other name: stereotactic external-beam radiation therapy
other name: Stereotactic Radiation Therapy
other name: Stereotactic Radiotherapy
other name: stereotaxic radiation therapy
other name: stereotaxic radiosurgery
intervention type: Procedure
intervention name: Therapeutic Conventional Surgery
description: Undergo surgical resection
arm group label: Treatment (capecitabine, celecoxib, radiation therapy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stacey Cohen
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Stacey Cohen
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Rectal Neoplasms
mesh term: Colonic Neoplasms
mesh term: Recurrence
mesh term: Celecoxib
mesh term: Capecitabine
mesh term: Benzenesulfonamide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 