COLLISION-XL trial: Unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation - a phase II prospective randomized controlled trial for CRLM 3-5 cm

Recruiting

Conditions: colorectal liver metastases
large bowel cancer liver metastases
10017990
10027476
10019818

Registration Number: NL-OMON52908

Lead Sponsor: Radiologie en nucleaire geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 68

Inclusion Criteria

• Histological documentation of primary colorectal tumour;
• 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target
lesions);
• Additional unresectable CRLM < 3 cm should be ablatable;
• Additional unablatable CRLM should be resectable;
• No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not
including positive para-aortal lymph nodes, celiac lymph nodes, adrenal
metastases, pleural carcinomatosis or peritoneal carcinomatosis);
• Maximum number of total CRLM is 5 if there is extrahepatic disease and 10 if
there is no extrahepatic disease;
• Unsuitable for (further) chemotherapy regimens
• Resection for resectable lesions considered possible obtaining negative
resection margins (R0) and preserving adequate liver reserve
• Previous radiotherapy, surgical resection or focal ablative therapy for CRLM
prior to inclusion are allowed;
• Age >18 years;
• Written informed consent

Exclusion Criteria

• Pregnant or breast-feeding subjects;
• Immunotherapy <= 6 weeks prior to the procedure;
• Chemotherapy <= 6 weeks prior to the procedure;
• Severe allergy to contrast media not controlled with premedication;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is local tumour progression free survival (LTPFS) at 1 year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are overall survival (OS), Local tumour progression free<br /><br>survival time, disease-free survival (DFS), time to progression (TTP), distant<br /><br>progression free survival (DPFS), procedural morbidity/toxicity and mortality,<br /><br>assessment of pain and quality of life (QoL) and cost-effectiveness ratio<br /><br>(ICER).</p><br>