Randomized phase II trial evaluating the feasibility and tolerance of the combination of FOLFOX with cetuximab and the combination of FOLFOX with cetuximab and bevacizumab as perioperative treatment in patients with resectable liver metastases from colorectal cancer. - BOS
- Conditions
- resectable liver metastases of colorectal cancer
- Registration Number
- EUCTR2005-002825-29-SE
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
-male or female patients with potentially resectable liver metastases from CRC
-patients with metachronous or synchronous metastases who have undergone comlete resection (R0) of the primary tumour at least 4 weeks before randomization into the study
-no evidence of extra-hepatic disease
-patients can be entered in the study irrespective of the EGFR-expression status of their CRC
-WHO performance status: 0,1
-age: 18 to 80 years
-no previous chemotherapy for metastatic disease
-any previous adjuvant chemotherapy for primary cancer is allowed, except for patients who ended an oxaliplatin containing adjuvant treatment less than 12 months ago, and except for patients with persisting neuropathy
-no previous exposure to EGFR- or VEGF/VEGFR-targeting therapy
-absolute neutrophil count > 1.5 x 109 /L, platelets > 100 x 109/L, hemoglobin > 9 g/dL, and white blood cell count (WBC) > 3 x 109 /L
-serum creatinine less than 1.5 times the upper limit of normal (ULN); no significant proteinuria (>500 mg/24 hours urine collection)
-written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
- peripheral neuropathy and serious nonhealing wound, ulcer, or bone fracture
- clinically significant cardiovascular disease
- pregnancy or breast feeding. Adequate contraception is required for both male and female patienst if the risk of conception exists. Methods of adequate contraception are: condon use with spermicide, hormonal contraception, intra-uterine device
- participation in another clinical study within the 30 days before randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method