- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03279601
Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor
September 10, 2017 updated by: Shen Lin, Peking University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
148
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed well-differentiated neuroendocrine tumor;
- 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;
- 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);
- 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;
- KPS ≥ 70;
- Predicted survival >=3 months;
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Exclusion Criteria:
- Hypersensitivity to capecitabine, dacarbazine or temozolomide;
- 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;
- Received surgery within past 4 weeks, or have not recovered from surgery;
- Severe diarrhea;
- Concurrent severe infection;
- 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);
- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment);
- Meningeal carcinomatosis;
- Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease;
- 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;
- Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- 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;
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Capecitabine: 1000mg/m2 ,p.o.
bid d1-14 q4W, Temozolomide: 200mg/m2 ,p.o.
bid d10-14 q4W,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, every 8 weeks up to 1 year after last patient first treatment
|
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
|
baseline, every 8 weeks up to 1 year after last patient first treatment
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
September 10, 2017
First Submitted That Met QC Criteria
September 10, 2017
First Posted (Actual)
September 12, 2017
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
September 10, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
- Capecitabine
- Dacarbazine
Other Study ID Numbers
- CAPDTIC vs. CAPTEM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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