<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/NCT02256982</url>
  </required_header>
  <id_info>
    <org_study_id>14-275</org_study_id>
    <nct_id>NCT02256982</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma</brief_title>
  <official_title>A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is evaluating the use of radiation therapy in combination with&#xD;
      chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of&#xD;
      gastrointestinal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to assess the possibility of using radiation therapy to treat intrahepatic&#xD;
      cholangiocarcinoma. Radiation therapy is used for many other types of malignancies, but its&#xD;
      use for the treatment of this form of gastrointestinal cancer has been limited. This&#xD;
      treatment is still being studied as research doctors are trying to find out more about its&#xD;
      use in the treatment of your form of gastrointestinal cancer. Short course photon radiation&#xD;
      and short course proton beam radiation therapies are FDA (U.S. Food and Drug Administration)&#xD;
      approved radiation delivery systems. This study will also test the safety of neoadjuvant&#xD;
      chemotherapy versus adjuvant chemotherapy. Neoadjuvant therapy is treatment given as a first&#xD;
      step to shrink a tumor before the main treatment, which is usually surgery, is given.&#xD;
      Adjuvant therapy is additional cancer treatment given after the primary treatment to lower&#xD;
      the risk that the cancer will come back.&#xD;
&#xD;
      The current standard of care for patients with intrahepatic cholangiocarcinoma is to offer&#xD;
      surgical resection to all patients who have resectable disease and are able to tolerate a&#xD;
      major surgical intervention.&#xD;
&#xD;
      The study interventions involved this trial may include one or more of the following:&#xD;
&#xD;
        -  Chemotherapy (Gemcitabine and Cisplatin)&#xD;
&#xD;
        -  Surgical Resection and Lymphadenectomy&#xD;
&#xD;
        -  Radiation Therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Post Operative/Radiation Therapy Complications</measure>
    <time_frame>90 Days</time_frame>
    <description>Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Unresectable Intrahepatic Cholangiocarcinoma</condition>
  <condition>Resectable Intrahepatic Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Resectable Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to surgery&#xD;
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unresectable Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to radiation therapy with protons or photons, determined by available resources&#xD;
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <arm_group_label>Resectable Disease</arm_group_label>
    <arm_group_label>Unresectable Disease</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>Resectable Disease</arm_group_label>
    <arm_group_label>Unresectable Disease</arm_group_label>
    <other_name>Platinol®</other_name>
    <other_name>Platinol-AQ®</other_name>
    <other_name>cis-DDP</other_name>
    <other_name>cis-Platinum II</other_name>
    <other_name>cis-Diamminedichloroplatinum</other_name>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Surgical Resection and Lymphadenectomy</description>
    <arm_group_label>Resectable Disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Radiation Therapy</description>
    <arm_group_label>Unresectable Disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must meet the following criteria on screening examination to be eligible&#xD;
             to participate in the study:&#xD;
&#xD;
          -  Participants must have histologically confirmed Intrahepatic Cholangiocarcinoma (IHC)&#xD;
             without evidence of extrahepatic metastasis.&#xD;
&#xD;
          -  Participants must have measurable disease, defined as at least one lesion that can be&#xD;
             accurately measured in at least one dimension (longest diameter to be recorded) as ≥&#xD;
             20 mm with conventional techniques or as ≥10 mm with spiral CT scan.&#xD;
&#xD;
          -  Participants with resectable disease must have a single tumor (with no satellite&#xD;
             lesions) with a total diameter or longest dimension of ≤ 20cm. Patients with&#xD;
             unresectable disease must have a total tumor diameter of &lt;20cm and ≤ 3 lesions.&#xD;
             Satellite lesions defined as lesions ≤ 2cm from the dominant lesion are permitted for&#xD;
             participants with unresectable disease&#xD;
&#xD;
          -  Patients are not allowed to receive prior surgery or chemotherapy for the IHC.&#xD;
&#xD;
          -  Patients with age ≥18 will be included in the study.&#xD;
&#xD;
          -  Expected survival must be three months or greater.&#xD;
&#xD;
          -  ECOG performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix A).&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500/mcL&#xD;
&#xD;
               -  Platelets ≥ 100,000/mcL&#xD;
&#xD;
               -  Total bilirubin ≤ 2.5 mg/dl&#xD;
&#xD;
               -  AST (SGOT)/ALT (SGPT) ≤ 5.0 X institutional upper limit of normal&#xD;
&#xD;
               -  Creatinine within normal institutional limits or creatinine clearance ≥ 60&#xD;
                  mL/min/1.73 m2 for subjects with creatinine levels above institutional normal .&#xD;
&#xD;
          -  No other known active secondary primary malignancy.&#xD;
&#xD;
          -  If patient has underlying cirrhosis, only Child-Pugh classification Group A patients&#xD;
             may be included in the resectable cohort of this study. For patients with unresectable&#xD;
             disease, Child-Pugh classification Groups A and B are allowed. Clinical assessment of&#xD;
             ascites and encephalopathy is required. Child-Pugh classification must be determined&#xD;
             for all study participants at the time of eligibility analysis. Note albumin and&#xD;
             PT/INR are required for Child-Pugh classification; these labs should be drawn with the&#xD;
             other labs required for eligibility analysis.&#xD;
&#xD;
        Table 1: Child-Pugh classification of liver function&#xD;
&#xD;
          -  Score 1 2 3&#xD;
&#xD;
               -  Ascites Absent Slight to moderate Severe&#xD;
&#xD;
               -  Encephalopathy Absent Slight to moderate Severe&#xD;
&#xD;
               -  Serum albumin &gt;3.5 g/dl 3-3.5 g/dl &lt;3 g/dl&#xD;
&#xD;
               -  Serum bilirubin &lt;2 mg/dl 2-3 mg/dl &gt;3 mg/dl&#xD;
&#xD;
               -  Prolongation of prothrombin time &lt;4 seconds 4-6 seconds &gt;6 seconds&#xD;
&#xD;
          -  Score of 5 to 6 corresponds to Child-Pugh class A&#xD;
&#xD;
          -  Score of 7 to 11 corresponds to Child-Pugh class B&#xD;
&#xD;
          -  Score of 12 to 15 corresponds to Child-Pugh class&#xD;
&#xD;
          -  The effects of gemcitabine+cisplatin on the developing human fetus are unknown. For&#xD;
             this reason, women of child-bearing potential and men must agree to use adequate&#xD;
             contraception (hormonal or barrier method of birth control; abstinence) prior to study&#xD;
             entry and for the duration of study treatment. Should a woman become pregnant or&#xD;
             suspect she is pregnant while participating in this study, she should inform her&#xD;
             treating physician immediately. Female patients of child bearing potential must&#xD;
             indicate to their physician that they are not pregnant at the time of enrollment or&#xD;
             have a negative serum pregnancy test.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who exhibit any of the following conditions at screening will not be&#xD;
             eligible for admission into the study.&#xD;
&#xD;
          -  Participants who have had chemotherapy or radiotherapy for intrahepatic&#xD;
             cholangiocarcinoma.&#xD;
&#xD;
          -  Participants receiving any other anti-cancer or investigational agents.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to gemcitabine or cisplatin.&#xD;
&#xD;
          -  Women who are pregnant or lactating.&#xD;
&#xD;
          -  Participants with evidence of non-hepatic metastatic disease.&#xD;
&#xD;
          -  Local conditions or systemic illnesses which would reduce the local tolerance to&#xD;
             radiation treatment, such as serious local injuries, active collagen vascular disease,&#xD;
             etc.&#xD;
&#xD;
          -  Participants with a serious medical illness which may limit expected survival to less&#xD;
             than 3 months.&#xD;
&#xD;
          -  Participants with serious psychiatric illness or social situations which would limit&#xD;
             adherence to study requirements.&#xD;
&#xD;
          -  Participants receiving any medications or substances that are strong inhibitors or&#xD;
             inducers of CYP3A4 are ineligible.&#xD;
&#xD;
          -  Because no dosing or adverse event data are currently available on the use of&#xD;
             gemcitabine+cisplatin in participants &lt;18 years of age, children are excluded from&#xD;
             this study.&#xD;
&#xD;
          -  Patients who require anticoagulation should receive low-molecular weight or standard&#xD;
             heparin and not warfarin.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Pregnant women are excluded from this study because gemcitabine is a class D agent&#xD;
             with the potential for teratogenic or abortifacient effects. Because there is an&#xD;
             unknown but potential risk of adverse events in nursing infants secondary to treatment&#xD;
             of the mother with gemcitabine, breastfeeding should be discontinued if the mother is&#xD;
             treated with gemcitabine. These potential risks may also apply to other agents used in&#xD;
             this study.&#xD;
&#xD;
          -  Individuals with a history of a different malignancy are ineligible except for the&#xD;
             following circumstances. Individuals with a history of other malignancies are eligible&#xD;
             if they have been disease-free for at least 5 years and are deemed by the investigator&#xD;
             to be at low risk for recurrence of that malignancy. Individuals with the following&#xD;
             cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer&#xD;
             in situ, DCIS, stage I prostate cancer, and basal cell or squamous cell carcinoma of&#xD;
             the skin.&#xD;
&#xD;
          -  HIV-positive individuals on combination antiretroviral therapy are ineligible because&#xD;
             of the potential for pharmacokinetic interactions with gemcitabine+cisplatin. In&#xD;
             addition, these individuals are at increased risk of lethal infections when treated&#xD;
             with marrow-suppressive therapy. Appropriate studies will be undertaken in&#xD;
             participants receiving combination antiretroviral therapy when indicated. HIV-positive&#xD;
             individuals on HAART will be considered eligible of they have demonstrated good&#xD;
             compliance and have a CD4 count &gt; 500.&#xD;
&#xD;
          -  Prior liver directed radiation.&#xD;
&#xD;
          -  Patients with peripheral neuropathy ≥ grade 2.&#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>Theodore S. Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <results_first_submitted>April 11, 2016</results_first_submitted>
  <results_first_submitted_qc>April 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 13, 2016</results_first_posted>
  <last_update_submitted>April 11, 2016</last_update_submitted>
  <last_update_submitted_qc>April 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Theodore Sunki Hong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>unresectable intrahepatic cholangiocarcinoma</keyword>
  <keyword>resectable intrahepatic cholangiocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 3 patients were enrolled between November 2014 and July 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Resectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to surgery&#xD;
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Surgery: Surgical Resection and Lymphadenectomy</description>
        </group>
        <group group_id="P2">
          <title>Unresectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to radiation therapy with protons or photons, determined by available resources&#xD;
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Radiation: Radiation Therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Resectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to surgery&#xD;
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Surgery: Surgical Resection and Lymphadenectomy</description>
        </group>
        <group group_id="B2">
          <title>Unresectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to radiation therapy with protons or photons, determined by available resources&#xD;
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Radiation: Radiation Therapy</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="3"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Post Operative/Radiation Therapy Complications</title>
        <description>Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.</description>
        <time_frame>90 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resectable Disease</title>
            <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to surgery&#xD;
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Surgery: Surgical Resection and Lymphadenectomy</description>
          </group>
          <group group_id="O2">
            <title>Unresectable Disease</title>
            <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to radiation therapy with protons or photons, determined by available resources&#xD;
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Radiation: Radiation Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Post Operative/Radiation Therapy Complications</title>
          <description>Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Resectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to surgery&#xD;
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Surgery: Surgical Resection and Lymphadenectomy</description>
        </group>
        <group group_id="E2">
          <title>Unresectable Disease</title>
          <description>Consent and Registration&#xD;
3 cycles of gemcitabine + cisplatin&#xD;
Evaluate for surgery* (weeks 10-15)&#xD;
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.&#xD;
Proceed to radiation therapy with protons or photons, determined by available resources&#xD;
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist&#xD;
Gemcitabine&#xD;
Cisplatin&#xD;
Radiation: Radiation Therapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Ted Hong, MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-6050</phone>
      <email>tshong1@partners.org</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/NCT02256982
org study id: 14-275
nct id: NCT02256982
lead sponsor: 
has dmc: Yes
This research study is evaluating the use of radiation therapy in combination with
      chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of
      gastrointestinal cancer.
This study is to assess the possibility of using radiation therapy to treat intrahepatic
      cholangiocarcinoma. Radiation therapy is used for many other types of malignancies, but its
      use for the treatment of this form of gastrointestinal cancer has been limited. This
      treatment is still being studied as research doctors are trying to find out more about its
      use in the treatment of your form of gastrointestinal cancer. Short course photon radiation
      and short course proton beam radiation therapies are FDA (U.S. Food and Drug Administration)
      approved radiation delivery systems. This study will also test the safety of neoadjuvant
      chemotherapy versus adjuvant chemotherapy. Neoadjuvant therapy is treatment given as a first
      step to shrink a tumor before the main treatment, which is usually surgery, is given.
      Adjuvant therapy is additional cancer treatment given after the primary treatment to lower
      the risk that the cancer will come back.

      The current standard of care for patients with intrahepatic cholangiocarcinoma is to offer
      surgical resection to all patients who have resectable disease and are able to tolerate a
      major surgical intervention.

      The study interventions involved this trial may include one or more of the following:

        -  Chemotherapy (Gemcitabine and Cisplatin)

        -  Surgical Resection and Lymphadenectomy

        -  Radiation Therapy
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Post Operative/Radiation Therapy Complications
time frame: 90 Days
description: Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.
arm group label: Resectable Disease
arm group type: Experimental
description: Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to surgery
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist
arm group label: Unresectable Disease
arm group type: Experimental
description: Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to radiation therapy with protons or photons, determined by available resources
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
intervention type: Drug
intervention name: Gemcitabine
arm group label: Resectable Disease
arm group label: Unresectable Disease
other name: Gemzar
intervention type: Drug
intervention name: Cisplatin
arm group label: Resectable Disease
arm group label: Unresectable Disease
other name: Platinol®
other name: Platinol-AQ®
other name: cis-DDP
other name: cis-Platinum II
other name: cis-Diamminedichloroplatinum
other name: DDP
intervention type: Procedure
intervention name: Surgery
description: Surgical Resection and Lymphadenectomy
arm group label: Resectable Disease
intervention type: Radiation
intervention name: Radiation
description: Radiation Therapy
arm group label: Unresectable Disease
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theodore S. Hong, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Theodore Sunki Hong
investigator title: Principal Investigator
mesh term: Cholangiocarcinoma
mesh term: Cisplatin
mesh term: Gemcitabine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 