Back to resultsFOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
Primary Purpose
Colorectal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Irinotecan
5-fluorouracil
Leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOLFIRI
IRINOTECAN
Arm Description
5-fluorouracil,folinate combined with irinotecan
irinotecan
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival
overall response rate
Number of Participants with Adverse Events
quality of life questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02935764
Brief Title
FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
Official Title
Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
5-fluorouracil,folinate combined with irinotecan
Arm Title
IRINOTECAN
Arm Type
Active Comparator
Arm Description
irinotecan
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180 mg/m2 iv gtt, d1
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
LV
Intervention Description
400mg/m2 iv gtt,d1
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
2 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
6 months
Title
overall response rate
Time Frame
2 months
Title
Number of Participants with Adverse Events
Time Frame
2 months
Title
quality of life questionnaire
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
35069808
Citation
Zhang X, Duan R, Wang Y, Liu X, Zhang W, Zhu X, Chen Z, Shen W, He Y, Wang HQ, Huang M, Wang C, Zhang Z, Zhao X, Qiu L, Luo J, Sheng X, Guo W. FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial. Ther Adv Med Oncol. 2022 Jan 13;14:17588359211068737. doi: 10.1177/17588359211068737. eCollection 2022.
Results Reference
derived
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FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
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