- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02935764
FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
October 14, 2016 updated by: Weijian Guo, Fudan University
Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients
This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
164
Phase
- Phase 3
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- Eastern Cooperative Oncology Group performance status of 0 to 2
- life expectancy of ≥ 3 months
- patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
- at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
- have adequate bone marrow, hepatic, and renal function
Exclusion Criteria:
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- patients with symptomatic brain metastases
- active clinical severe infection
- previously received irinotecan
- dihydropyrimidine dehydrogenase (DPD) enzyme adequate
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: FOLFIRI
5-fluorouracil,folinate combined with irinotecan
|
180 mg/m2 iv gtt, d1
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
Other Names:
400mg/m2 iv gtt,d1
Other Names:
|
Active Comparator: IRINOTECAN
irinotecan
|
180 mg/m2 iv gtt, d1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 6 months
|
6 months
|
overall response rate
Time Frame: 2 months
|
2 months
|
Number of Participants with Adverse Events
Time Frame: 2 months
|
2 months
|
quality of life questionnaire
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2016
Primary Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Estimate)
October 17, 2016
Last Update Submitted That Met QC Criteria
October 14, 2016
Last Verified
October 1, 2016
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
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Leucovorin
- Irinotecan
Other Study ID Numbers
- FDZL-FCI
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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