FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
Phase 3
- Conditions
- Colorectal Carcinoma
- Interventions
- Registration Number
- NCT02935764
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 164
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOLFIRI Irinotecan 5-fluorouracil,folinate combined with irinotecan FOLFIRI 5-fluorouracil 5-fluorouracil,folinate combined with irinotecan IRINOTECAN Irinotecan irinotecan FOLFIRI Leucovorin 5-fluorouracil,folinate combined with irinotecan
- Primary Outcome Measures
Name Time Method progression free survival 2 months
- Secondary Outcome Measures
Name Time Method overall survival 6 months overall response rate 2 months Number of Participants with Adverse Events 2 months quality of life questionnaire 2 months