EUCTR2013-005435-24-NL
Active, not recruiting
Phase 1
Treatment strategies in colorectal cancer patients with initially irresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG) - CAIRO5
Dutch Colorectal Cancer Group0 sites584 target enrollmentFebruary 4, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dutch Colorectal Cancer Group
- Enrollment
- 584
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Histologically proven colorectal cancer
- •\-Irresectable metastases confined to the liver according to CT scan, obtained \= 4 weeks prior to randomization. Irresectability should be confirmed by the panel. Patients with small (\= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- •\-Adequate tumor tissue available for central assessment of RAS/BRAF mutation status
- •\-WHO performance status 0\-2 (Karnofsky performance \= 70\)
- •\-Age \= 18 years
- •\-No contraindications for liver surgery
- •\-in case of synchronous metastatses: resectable primary tumor, or adequate clinical recovery in case of immediate surgery of primary tumor
- •\-Adequate organ functions, as determined by normal bone marrow function (Hb ³ 6\.0 mmol/L, absolute neutrophil count ³ 1\.5 x 109/L, platelets ³ 100 x 109/L), renal function (serum creatinine \= 1\.5x ULN and creatinine clearance, Cockroft formula, ³ 30 ml/min), liver function (serum bilirubin \= 2 x ULN, serum transaminases \= 5x ULN)
- •\-Life expectancy \> 12 weeks
- •\-Expected adequacy of follow\-up
Exclusion Criteria
- •\-Extrahepatic metastases, with the exception of small (\= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases
- •\-Irresectable primary tumor, or resectable tumor requiring immediate surgery
- •\-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 of randomization
- •\-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 randomization
- •\-Previous intolerance of study drugs in the adjuvant setting
- •\-Pregnant or lactating women
Outcomes
Primary Outcomes
Not specified
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