NCT02935764
Unknown
Phase 3
Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients
ConditionsColorectal Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Irinotecan
- Conditions
- Colorectal Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 164
- Primary Endpoint
- progression free survival
- Last Updated
- 9 years ago
Overview
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.
Investigators
Weijian Guo
Vice Director of Department of Medical Oncology, Clinical Professor
Fudan University
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
Arms & Interventions
FOLFIRI
5-fluorouracil,folinate combined with irinotecan
Intervention: Irinotecan
FOLFIRI
5-fluorouracil,folinate combined with irinotecan
Intervention: 5-fluorouracil
FOLFIRI
5-fluorouracil,folinate combined with irinotecan
Intervention: Leucovorin
IRINOTECAN
irinotecan
Intervention: Irinotecan
Outcomes
Primary Outcomes
progression free survival
Time Frame: 2 months
Secondary Outcomes
- overall survival(6 months)
- overall response rate(2 months)
- Number of Participants with Adverse Events(2 months)
- quality of life questionnaire(2 months)
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