Colorectal Carcinoma
Conditions
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.
Interventions
DRUG5-fluorouracil
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
DRUGLeucovorin
400mg/m2 iv gtt,d1
DRUGIrinotecan
180 mg/m2 iv gtt, d1
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 6 months |
| overall response rate | 2 months |
| Number of Participants with Adverse Events | 2 months |
| quality of life questionnaire | 2 months |
Outcome results
None listed