COLLISION trial - Colorectal liver metastases: surgery versus thermal ablation - a phase III prospective randomized controlled trial

Phase 3

Recruiting

Conditions: 10019818
Colorectal cancer liver metastases
Metastatic colorectal cancer
10017990
10027476

Registration Number: NL-OMON54713

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 637

Inclusion Criteria

• Histological documentation of primary colorectal tumor;
• 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;
• Resection for resectable lesions considered possible obtaining negative
resection margins (R0) and preserving adequate liver reserve
• Resectability and ablatability should be re-confirmed intra-operatively by US
plus full exploration for hepatic, peritoneal and regional lymph node
metastases;
• Age >18 years;
• Eastern Cooper ative Oncology Group performance status (ECOG) 0-2;
• American Society of Anesthesiologists (ASA) grade 1-3;
• Life expectancy of at least 12 weeks;
• Written informed consent

Exclusion Criteria

• Pregnant or breast-feeding subjects. Women of childbearing potential must
have a negative pregnancy test performed within 7 days of the start of
treatment;
• Immunotherapy <= 6 weeks prior to the procedure;
• Chemotherapy <= 6 weeks prior to the procedure;
• Any surgical resection or focal ablative liver therapy for CRLM prior to
inclusion;
• Severe allergy to contrast media not controlled with premedication;
• Patients with only one or two small-size (0-3cm) and anatomically
deep-seated (defined as requiring major hepatectomy) CRLM in a single liver
lobe

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is OS (intention-to-treat analysis).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Main secondary endpoints are overall disease-free survival (DFS), time to<br /><br>progression (TTP), time to local progression (TTLP), primary and assisted<br /><br>technique efficacy (PTE, ATE), procedural morbidity and mortality, length of<br /><br>hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness<br /><br>ratio (ICER) and quality-adjusted life years (QALY).</p><br>