Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG) - CAIRO5

Dutch Colorectal Cancer Group0 个研究点目标入组 584 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Histologically proven colorectal cancer , - unresectable metastases confined
•to the liver according to CT scan, obtained <= 2 weeks prior to registration.
•Unresectability will be confirmed by the panel. Patients with small (<= 1 cm)
•extrahepatic lesions that are not clearly suspicious of metastases are
•eligible., - RAS/BRAF mutation status known, - 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
•- In case of resected primary tumor: adequate recovery from surgery, - 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 or more, - Expected
•adequacy of follow-up, - Written informed consent

•- Extrahepatic metastases, with the exception of small (<= 1 cm) extrahepatic
•lesions that are not clearly suspicious for metastases , - Unresectable 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 before registration, - 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 registration, - 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

发起方

Dutch Colorectal Cancer Group