Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer
Incurable Colorectal Cancer, RAS-wild-type
About this trial
This is an interventional treatment trial for Incurable Colorectal Cancer focused on measuring Incurable colorectal cancer, maintenance therapy, Cetuximab
Eligibility Criteria
Inclusion Criteria:
- Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
- Eastern Cooperative Oncology Group performance status ≤2 and
- life expectancy of >3 months were enrolled.
- All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
- None was previous exposure to Cetuximab or irinotecan .
- Patients had to have adequate haematological (absolute neutrophil count >1.5 × 109/l; platelet count >100 × 109/l; haemoglobin >9 g/dl), hepatic [total bilirubin <1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase <2.5 × ULN, or <5 × ULN in the case of hepatic metastases or <10 × ULN in the case of osseous metastases; alkaline phosphatase <2.5 × ULN, or <5 × ULN or <10 × ULN in the case of hepatic or osseous metastases, respectively] and renal function (creatinine clearance ≥60 ml/min)
- All RAS were wildtype. -
Exclusion Criteria:
- Pregnant or breast-feeding women;
- Clinically significant cardiac disease;
- Lack of physical integrity of the upper gastrointestinal tract;
- History of other malignancy;
- Central nervous system metastases. -
Sites / Locations
- Zhongshan Hospital Affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Experimental
maintenance therapy
Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped