<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/NCT03279601</url>
  </required_header>
  <id_info>
    <org_study_id>CAPDTIC vs. CAPTEM</org_study_id>
    <nct_id>NCT03279601</nct_id>
  </id_info>
  <brief_title>Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor</brief_title>
  <official_title>A Randomized, Controlled Phase II Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be conducted to compare the safety and efficacy of Capecitabine Combined With&#xD;
      Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic&#xD;
      gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective&#xD;
      randomized phase II study, the investigators aim to compare the survival benefit as well as&#xD;
      the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined&#xD;
      Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal&#xD;
      neuroendocrine tumor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>baseline, every 8 weeks up to 1 year after last patient first treatment</time_frame>
    <description>Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>baseline, every 8 weeks up to 1 year after last patient first treatment</time_frame>
    <description>Overall survival is defined as the time from date of start of treatment to date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）</measure>
    <time_frame>From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>A: Capecitabine Combined With Dacarbazine(CAPDTIC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: Capecitabine Combined Temozolomide(CAPTEM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o.d10-14 q4W</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine, Dacarbazine</intervention_name>
    <description>Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W</description>
    <arm_group_label>A: Capecitabine Combined With Dacarbazine(CAPDTIC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine, Temozolomide</intervention_name>
    <description>Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,</description>
    <arm_group_label>B: Capecitabine Combined Temozolomide(CAPTEM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. sign written informed consent form&#xD;
&#xD;
          2. age ≥ 18 years&#xD;
&#xD;
          3. pathologically confirmed well-differentiated neuroendocrine tumor;&#xD;
&#xD;
          4. No prior antitumor treatment of capecitabine, dacarbazine or temozolomide. For&#xD;
             recurrent patients after radical surgery, adjuvant chemotherapy should not include&#xD;
             capecitabine, dacarbazine or temozolomide, and the last date should beyond 6 months&#xD;
             prior to randomization;&#xD;
&#xD;
          5. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded)&#xD;
             (routine CT scan &gt;=20mm, spiral CT scan &gt;=10mm, no prior radiation to measurable&#xD;
             lesions);&#xD;
&#xD;
          6. Screening laboratory values must meet the following criteria (within past 7 days):&#xD;
             hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total&#xD;
             bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine&#xD;
             transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum&#xD;
             creatinine ≤1╳ULN;&#xD;
&#xD;
          7. KPS ≥ 70;&#xD;
&#xD;
          8. Predicted survival &gt;=3 months;&#xD;
&#xD;
          9. Negative serum or urine pregnant test within 7 days prior to randomization for&#xD;
             child-bearing age women;&#xD;
&#xD;
         10. Sexually active males or females willing to practice contraception during the study&#xD;
             until 30 days after end of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to capecitabine, dacarbazine or temozolomide;&#xD;
&#xD;
          2. Prior antitumor therapy (including corticosteroids and immunotherapy) or participation&#xD;
             in other clinical trials within past 4 weeks, or have not recovered from toxicities&#xD;
             since the last treatment;&#xD;
&#xD;
          3. Received surgery within past 4 weeks, or have not recovered from surgery;&#xD;
&#xD;
          4. Severe diarrhea;&#xD;
&#xD;
          5. Concurrent severe infection；&#xD;
&#xD;
          6. Severe, uncontrolled medical condition that would affect patients' compliance or&#xD;
             obscure the interpretation of toxicity determination or adverse events, including&#xD;
             severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or&#xD;
             hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary&#xD;
             disease or symptomatic bronchospasm);&#xD;
&#xD;
          7. Prior long term steroid therapy (excluding short term steroid treatment which is&#xD;
             completed prior to &gt; 2 weeks of study enrollment)；&#xD;
&#xD;
          8. Meningeal carcinomatosis;&#xD;
&#xD;
          9. Patients with central nervous system(CNS) disorder or peripheral nervous system&#xD;
             disorder or psychiatric disease；&#xD;
&#xD;
         10. Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and&#xD;
             hypertension, or congestive heart failure, or cardiac infarction within 6 months prior&#xD;
             to study enrollment, or cardiac insufficiency；&#xD;
&#xD;
         11. Pregnant or nursing, or sexually active males or females refuse to practice&#xD;
             contraception during the study until 30 days after end of study;&#xD;
&#xD;
         12. History of other malignancy. However, subjects who have been disease-free for 5 years,&#xD;
             or subjects with a history of completely resected non-melanoma skin cancer or&#xD;
             successfully treated in situ carcinoma, are eligible；&#xD;
&#xD;
         13. Person with no capacity (legally) or inappropriate to continue study treatment for&#xD;
             ethics/medical reasons；&#xD;
&#xD;
         14. Underlying medical condition that, in the Investigator's opinion, would increase the&#xD;
             risks of study drug administration or obscure the interpretation of toxicity&#xD;
             determination or adverse events.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lin Shen</last_name>
    <phone>86-10-88196561</phone>
    <email>linshenpku@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shen Lin, Professor</last_name>
      <phone>010-88196561</phone>
      <email>Linshenpku@163.com</email>
    </contact>
    <investigator>
      <last_name>Shen Lin, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>chemotherapy</keyword>
  <keyword>OS</keyword>
  <keyword>ORR</keyword>
  <keyword>PFS</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03279601
org study id: CAPDTIC vs. CAPTEM
nct id: NCT03279601
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will be conducted to compare the safety and efficacy of Capecitabine Combined With
      Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic
      gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective
      randomized phase II study, the investigators aim to compare the survival benefit as well as
      the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined
      Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal
      neuroendocrine tumor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
description: CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
measure: Progression-free survival
time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
description: Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
measure: Overall survival
time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
description: Overall survival is defined as the time from date of start of treatment to date of death due to any cause
measure: Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）
time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
arm group label: A: Capecitabine Combined With Dacarbazine(CAPDTIC)
arm group type: Experimental
description: patients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W
arm group label: B: Capecitabine Combined Temozolomide(CAPTEM)
arm group type: Experimental
description: patients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o.d10-14 q4W
intervention type: Drug
intervention name: Capecitabine, Dacarbazine
description: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W
arm group label: A: Capecitabine Combined With Dacarbazine(CAPDTIC)
intervention type: Drug
intervention name: Capecitabine, Temozolomide
description: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,
arm group label: B: Capecitabine Combined Temozolomide(CAPTEM)
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lin Shen
phone: 86-10-88196561
email: linshenpku@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
mesh term: Neuroendocrine Tumors
mesh term: Capecitabine
mesh term: Temozolomide
mesh term: Dacarbazine
sharing ipd: No