COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation, a Phase III Single-blind Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 618
- 试验地点
- 2
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The primary objective is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable colorectal liver metastases (≤3cm) and no extrahepatic disease.
详细描述
Study design:
COLLISION is a single-blind prospective multi-center phase-III randomized controlled trial. We hypothesize that thermal ablation is non-inferior to surgery for the selected patient groups in terms of the primary objective (overall survival). The Cox proportional hazards model (1-sided; non-inferiority or superiority) is used for sample size calculations. Given the superior safety profile we consider a hazard ratio of 1.3 to represent the upper limit of non-inferiority (non-inferiority margin). An HR of 1.3 corresponds to a 56.5% chance of the ablated patients to die first ((P = HR/(1 + HR) = 1.3/(1 + 1.3) = 0.565 (56.5%)). With 3 years of patient accrual and five years of follow-up we will have reached 60% of events (death) in approximately 6.5 years (overall probability of event, pE =0.6). The calculated sample size therefore is 599 (NS).To account for a 10% drop-out ratio (NDO=69) prior to randomization and a 3% loss to follow-up (NLTFU=18) after randomization we need to include 687 patients (NI). A total number of 618 patients will be randomized (NR) into one of two arms: arm A will undergo surgical resection (n=309) and arm B thermal ablation (n=309) for appointed target lesions.
Study population:
Patients with ≥1 resectable and ablatable CRLM (≤3cm), no extrahepatic disease and a good performance status (WHO 0-2) are considered eligible. Supplementary resections for resectable lesions >3cm and thermal ablations for unresectable CRLM ≤3cm are allowed with a maximum number of CRLM of 10.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Most important inclusion criteria:
- •At least one CRLM size ≤ 3 cm eligible for both surgical resection and thermal ablation (target lesions);
- •Additional unresectable CRLM should be ≤ 3 cm and ablatable (unresectable lesions);
- •Additional unablatable CRLM should be resectable (unablatable lesions);
- •Maximum number of CRLM 10;
- •Resectability and ablatability should be re-confirmed intra-operatively by US plus full exploration for hepatic, peritoneal and regional lymph node metastases;
- •Most important
排除标准
- •No target lesions suitable for both resection and ablation;
- •Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
- •The presence of extrahepatic nodal or non-nodal metastases;
- •Immunotherapy or chemotherapy ≤ 6 weeks prior to the procedure;
- •Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion
结局指标
主要结局
Overall survival (OS)
时间窗: 5 years
Counting from the date of randomization to the date of death of the patient or to the last day of follow-up.
次要结局
- Disease free survival(5 years)
- Time to progression(5 years)
研究者
Dr. M.R. Meijerink
Dr
Amsterdam UMC, location VUmc