High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Irinotecan, UGT1A1, Advanced Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence
- Patients should be with UGT1A1*28 wild-type TA6/6 and UGT1A1*6 wild-type G/G
- Patients have measurable lesions
- Patients are not available for targeted therapy or patients refuse to receive targeted therapy
- Age should be more than 18 years
- Performance status should be 0-2
- Hemoglobin should be more than 9.0 g/dL; Absolute Neutrophil Count should be more than 1,500/mm3; Platelet should be more than 80,000/mm3;Total Bilirubin should be less than 1.5 times of the upper limit of normal value; Alanine aminotransferase and Glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); Creatinine should be be less than 1.5 times of the upper limit of normal value
Exclusion Criteria:
- Patients with UGT1A1*28 wild-type TA6/7, TA7/7 and UGT1A1*6 wild-type G/A,A/A;
- Patients with brain metastases;
- Patients could not tolerate chemotherapy;
- Patients have secondary primary tumor;
Sites / Locations
- Shanghai Changzheng HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
HD-FOLFIRI
SD-FOLFIRI
SD-FOLFOX-6
Advanced CRC patients with Wild-type UGT1A1*6 and *28 receive high-dose FOLFIRI regimen (Irinotecan 260mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course.)
Advanced CRC patients with Wild-type UGT1A1*6 and *28 receive standard-dose FOLFIRI regimen (Irinotecan 180mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)
Advanced CRC patients with Wild-type UGT1A1*6 and *28 receive standard-dose FOLFOX-6 regimen (Oxaliplatin 130mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)