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Trial record 16 of 1310 for:    survival | Neuroendocrine Tumors

Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor

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ClinicalTrials.gov Identifier: NCT03279601
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Tracking Information
First Submitted Date  ICMJE September 10, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 12, 2017
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
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 ]
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
  • Progression-free survival [ Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment ]
    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
  • Overall survival [ Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment ]
    Overall survival is defined as the time from date of start of treatment to date of death due to any cause
  • 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 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: Capecitabine, Dacarbazine
    Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ,iv drip,d1-5 q4W
  • Drug: Capecitabine, Temozolomide
    Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ,p.o. bid d10-14 q4W,
Study Arms  ICMJE
  • Experimental: A: Capecitabine Combined With Dacarbazine(CAPDTIC)
    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
    Intervention: Drug: Capecitabine, Dacarbazine
  • Experimental: B: Capecitabine Combined Temozolomide(CAPTEM)
    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: Drug: Capecitabine, Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2017)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. sign written informed consent form
  2. age ≥ 18 years
  3. pathologically confirmed well-differentiated neuroendocrine tumor;
  4. No prior antitumor treatment of capecitabine, dacarbazine or temozolomide. For recurrent patients after radical surgery, adjuvant chemotherapy should not include capecitabine, dacarbazine or temozolomide, and the last date should beyond 6 months prior to randomization;
  5. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
  6. Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
  7. KPS ≥ 70;
  8. Predicted survival >=3 months;
  9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
  10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

  1. Hypersensitivity to capecitabine, dacarbazine or temozolomide;
  2. Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  3. Received surgery within past 4 weeks, or have not recovered from surgery;
  4. Severe diarrhea;
  5. Concurrent severe infection;
  6. Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  7. Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment);
  8. Meningeal carcinomatosis;
  9. Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease;
  10. Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency;
  11. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  12. History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;
  13. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons;
  14. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lin Shen 86-10-88196561 linshenpku@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279601
Other Study ID Numbers  ICMJE CAPDTIC vs. CAPTEM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shen Lin, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP