<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/NCT04465162</url>
  </required_header>
  <id_info>
    <org_study_id>ID99-384</org_study_id>
    <secondary_id>NCI-2020-02549</secondary_id>
    <secondary_id>ID99-384</secondary_id>
    <nct_id>NCT04465162</nct_id>
  </id_info>
  <brief_title>Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma</brief_title>
  <official_title>Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies the side effects of radiation therapy used alone, and if it can achieve a&#xD;
      high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high&#xD;
      energy sources to kill cancer cells and shrink tumors. This treatment may improve the&#xD;
      patient's lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and&#xD;
      2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment&#xD;
      modalities.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 6-8 weeks, and then every&#xD;
      3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and&#xD;
      once yearly thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2000</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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>Relapse-free Survival (RFS)</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival (PFS)</measure>
    <time_frame>17.5 years</time_frame>
    <description>PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) at 10 Years</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 Year Overall Survival (OS)</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue</condition>
  <condition>Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue</condition>
  <condition>Extranodal Marginal Zone Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Treatment (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>Radiation Therapy, NOS</other_name>
    <other_name>Radiotherapeutics</other_name>
    <other_name>Radiotherapy</other_name>
    <other_name>RT</other_name>
    <other_name>Therapy, Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study&#xD;
&#xD;
          -  Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended&#xD;
             to have treatments with antibiotics prior to enrollment to this protocol&#xD;
&#xD;
          -  Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy&#xD;
             etc) are also eligible as far as they never had stage 3 or 4 disease during the course&#xD;
             of the disease or disease progression to the opposite side of the diaphragm (as the&#xD;
             time course of the response to antibiotic therapy can be very variable among patients,&#xD;
             sometimes requiring more than one year for complete response, failure to antibiotic&#xD;
             therapy can be very variable among patients, sometimes requiring more than one year&#xD;
             for complete response, failure to antibiotic treatment will be defined as no response&#xD;
             or progression of the disease documented by endoscopy and biopsy)&#xD;
&#xD;
          -  Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular&#xD;
             adnexal involvement or due to multiple sites within Waldeyer's ring will still be&#xD;
             eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had previous radiation dose to the site of the current primary disease&#xD;
             which would lead to violation of known radiation tolerance limit of that particular&#xD;
             site if treated again&#xD;
&#xD;
          -  Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm&#xD;
             will be ineligible&#xD;
&#xD;
          -  Previous or concurrent malignancy in any form would not be an exclusion criterion.&#xD;
             However, patients who receive chemotherapy for concurrent malignancy will be excluded&#xD;
             from statistical analysis&#xD;
&#xD;
          -  Low blood cell counts would not be exclusion criteria as far as the patient is willing&#xD;
             to accept supportive measures such as transfusions, filgrastim and epoetin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bouthaina S Dabaja</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <results_first_submitted>January 5, 2022</results_first_submitted>
  <results_first_submitted_qc>February 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2022</results_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT04465162/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>75 participants enrolled in study, 2 participants did not receive Radiation Therapy(RT); 1 owing to discovered stage III disease and 1 who chose observation after complete surgical resection of disease in a gastric polyp.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Radiation Therapy)</title>
          <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo 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="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Radiation Therapy)</title>
          <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="73"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" lower_limit="25" upper_limit="84"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Stage</title>
          <description>Stage I. This stage is usually a cancer that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body. It is often called early-stage cancer. Stage II and Stage III. In general, these 2 stages are cancers that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not to other parts of the body. Stage IV. This stage means that the cancer has spread to other organs or parts of the body. It may be also called advanced or metastatic cancer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor Location</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Head and neck (nonorbit)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orbit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomach</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Helicobacter pylori positive at initial diagnosis</title>
          <population>Participants with gastric Mucosa-Associated Lymphoid Tissue (MALT) and were Helicobacter pylori positive at the time of initial diagnosis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Treatment before radiation therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Antibiotics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rituximab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Radiation dose, Gy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>24-28.5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-30.6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>33-39.6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relapse-free Survival (RFS)</title>
        <description>RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.</description>
        <time_frame>Through study completion, up to 10 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Radiation Therapy)</title>
            <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Relapse-free Survival (RFS)</title>
          <description>RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="74" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Progression Free Survival (PFS)</title>
        <description>PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.</description>
        <time_frame>17.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Radiation Therapy)</title>
            <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Median Progression Free Survival (PFS)</title>
          <description>PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="11.5" upper_limit="NA">survival curve for upper limit does not cross 50% survival</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) at 10 Years</title>
        <description>PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.</description>
        <time_frame>Through study completion, up to 10 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Radiation Therapy)</title>
            <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) at 10 Years</title>
          <description>PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="60" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10 Year Overall Survival (OS)</title>
        <description>Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.</description>
        <time_frame>Through study completion, up to 10 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Radiation Therapy)</title>
            <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>10 Year Overall Survival (OS)</title>
          <description>Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="77" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose through 30 days after the last dose of study medication, All-Cause Mortality was assessed up to 10 years, and Serious and Other (Not Including Serious) adverse events were assessed up to 9 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Radiation Therapy)</title>
          <description>Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.&#xD;
Radiation Therapy: Undergo radiation therapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>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="28" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye toxicities</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Cataracts</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Xerostomia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Salivary</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Upper GI</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Lower GI</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Bone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Larynx</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Mucositis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Pharynx</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Skin</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="73"/>
              </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>Dr. Bouthaina S Dabaja, MD-Professor, Radiation Oncology Department</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 563-2406</phone>
      <email>bdabaja@mdanderson.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/NCT04465162
org study id: ID99-384
secondary id: NCI-2020-02549
secondary id: ID99-384
nct id: NCT04465162
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial studies the side effects of radiation therapy used alone, and if it can achieve a
      high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high
      energy sources to kill cancer cells and shrink tumors. This treatment may improve the
      patient's lymphoma.
PRIMARY OBJECTIVE:

      I. To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and
      2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment
      modalities.

      OUTLINE:

      Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.

      After completion of study treatment, patients are followed up at 6-8 weeks, and then every
      3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and
      once yearly thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relapse-free Survival (RFS)
time frame: Through study completion, up to 10 years
description: RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.
measure: Median Progression Free Survival (PFS)
time frame: 17.5 years
description: PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
measure: Progression Free Survival (PFS) at 10 Years
time frame: Through study completion, up to 10 years
description: PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.
measure: 10 Year Overall Survival (OS)
time frame: Through study completion, up to 10 years
description: Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.
arm group label: Treatment (radiation therapy)
arm group type: Experimental
description: Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
intervention type: Other
intervention name: Radiation Therapy
description: Undergo radiation therapy
arm group label: Treatment (radiation therapy)
other name: Cancer Radiotherapy
other name: Irradiate
other name: Irradiated
other name: Irradiation
other name: Radiation
other name: Radiation Therapy, NOS
other name: Radiotherapeutics
other name: Radiotherapy
other name: RT
other name: Therapy, Radiation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bouthaina S Dabaja
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell, Marginal Zone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 