RecruitingPhase 3NCT05861505

COLLISION RELAPSE Trial

COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial

Sponsor

Amsterdam UMC, location VUmc

Enrollment

360 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Surgery Liver Metastases Chemotherapy Effect Liver Metastasis Colon Cancer Recurrence

Summary

The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of extrahepatic disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (COLLISION RELAPSE) looks at whether adding local treatments — like surgery or heat-based ablation — to chemotherapy is better than chemotherapy alone for people whose colorectal cancer has spread to the liver and come back within a year of a prior local liver treatment. **You may be eligible if...** - You are over 18 years old - You have colorectal cancer that has spread to the liver, which was previously treated locally (surgery or ablation) and has now returned within 12 months - You have 5 or fewer new liver spots, and at least one can be treated locally again - Your cancer is confined to the liver (no spread elsewhere) - Your general health and liver function are adequate **You may NOT be eligible if...** - Your cancer has spread outside the liver - Your tumor has a specific mutation (MSI/dMMR) making it ineligible - You have had chemotherapy or immunotherapy in the past 6 weeks - You are pregnant or breastfeeding - Your liver function is severely compromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)

Standard first line systemic treatment: CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B CAPOX 4x (12 weeks) FOLFOX/FOLFIRI 6x (12 weeks) Maximum 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI +/- bevacizumab regardless of the location of primary tumor or RAS/BRAF mutation

OTHERRepeat local treatment

Choice of repeat local treatment is to the discretion of the local investigator, and may be selected on a per patient basis. The safety, feasibility and preferred type of surgical resection(s) is at the discretion of the liver surgeon (whether or not combined with thermal ablation). The safety, feasibility and preferred type of thermal ablation(s) is at the discretion of the interventional radiologist (whether or not combined with surgical resection).