Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases
Sponsored by Dutch Colorectal Cancer Group
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 11 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Histological proof of colorectal cancer
- Initially unresectable metastases confined to the liver according to CT scan, obtained ≤3 weeks prior to registration. Unresectability should be confirmed by the liver expertpanel. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible
- Known mutation status of RAS and BRAF
- WHO performance status 0-1 (Karnofsky performance status ≥ 70)
- Age ≥ 18 years
- No contraindications for liver surgery
- In case of primary tumor in situ: tumor should be resectable
- In case of resected primary tumor: adequate recovery from surgery
- Adequate organ functions, as determined by normal bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, ≥ 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 5x ULN)
- Life expectancy > 12 weeks
- Expected adequacy of follow-up
- Written informed consent
Exclusion Criteria
- Extrahepatic metastases, with the exception of small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases
- Unresectable primary tumor
- Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery)
- Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation
- Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs
- Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed ≥ 6 months prior to randomisation
- Previous surgery for metastatic disease
- Previous intolerance of study drugs in the adjuvant setting
- Pregnant or lactating women
- Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin, or second primary colorectal cancer.
- Any concomitant experimental treatment.