Neoadjuvant therapy followed by local treatment for recurrent colorectal liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COLLISION RELAPSE trial is a phase III randomized controlled trial designed to compare the effectiveness of neoadjuvant systemic therapy followed by repeat local treatment against upfront repeat local treatment in patients with recurrent colorectal liver metastases (CRLM). The study will enroll 360 patients who have experienced a recurrence within 12 months after initial treatment and have a good performance status. Participants will be randomized into two groups, with one receiving the neoadjuvant therapy for 12 weeks before local treatment, while the other will receive local treatment immediately. The primary objective is to demonstrate improved overall survival with the neoadjuvant approach.

Why it matters

Who can join: the full rules

Inclusion criteria

* Age \>18 years
* Good performance status (ECOG 0-2 // ASA 1-3)
* Histological documentation of primary colorectal tumor
* Local treatment performed for initial CRLM
* New recurrence ≤12 months
* ≥1 locally treatable CRLM (resectable\* and/or ablatable)
* Total number of new CRLM ≤5
* Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function
* Written informed consent Exclusion criteria
* Extrahepatic disease
* MSI/dMMR
* Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
* Pregnant or breast-feeding subjects
* Immuno- or chemotherapy ≤ 6 weeks prior to the randomization
* Severe allergy to contrast media not controlled with premedication
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results

ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair

\* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: M Dijkstra
• Email: interventieradiologie@vumc.nl
• Phone: +31(0)204444444

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.