- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230187
Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer (TRIBE-C)
Bevacizumab Plus mFOLFOXIRI or mFOLFOX-6 as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer: a Randomised, Open-label, Phase 3 Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- Gastrointestinal Hospital, Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
Subjects with metastatic colorectal cancer(CRC) (Stage IV). Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 12 months of completion of adjuvant therapy.
Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
Heart failure grade III/IV (NYHA-classification). Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
Subjects with known allergy to the study drugs or to any of its excipients. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Breast- feeding or pregnant women Lack of effective contraception.
Study Plan
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: mFOLFOXIRI Plus Bevacizumab
Patients will receive mFOLFOXIRI plus bevacizumab once every two weeks for 8 cycles as the first-line treatment.
|
Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment
Other Names:
|
Active Comparator: mFOLFOX6 Plus Bevacizumab
Patients will receive mFOLFOX6 plus bevacizumab once every two weeks for 8 cycles as the first-line treatment.
|
mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 2 years
|
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 2 years
|
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
|
2 years
|
Overall Survival (OS)
Time Frame: 5 years
|
OS is defined as the time from date of randomization to death due to any cause.
Subjects still alive at the time of analysis were censored at their last date of last contact.
|
5 years
|
Toxicity assessed using the NCI common toxicity criteria, version 5.0.
Time Frame: 2 years
|
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Irinotecan
- Levoleucovorin
Other Study ID Numbers
- GIHSYSU-18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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