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Trial record 16 of 1297 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

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Capecitabine, Dacarbazine Drug: Capecitabine, Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
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
Drug: Capecitabine, Dacarbazine
Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ,iv drip,d1-5 q4W

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
Drug: Capecitabine, Temozolomide
Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ,p.o. bid d10-14 q4W,




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279601


Contacts
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Contact: Lin Shen 86-10-88196561 linshenpku@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561    Linshenpku@163.com   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University

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Responsible Party: Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03279601     History of Changes
Other Study ID Numbers: CAPDTIC vs. CAPTEM
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shen Lin, Peking University:
chemotherapy
OS
ORR
PFS
safety

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Capecitabine
Temozolomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents