Neoadjuvant therapy followed by local treatment for recurrent colorectal liver metastases
COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial
This study is testing if giving a new treatment before local therapy can help people with recurrent colorectal liver cancer live longer compared to getting local therapy right away.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05861505 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a good performance status and at least one locally treatable recurrent colorectal liver metastasis.
Not a fit: Patients with extrahepatic disease or those for whom radical local treatment is unfeasible or unsafe will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved overall survival rates for patients with recurrent colorectal liver metastases.
How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: M Dijkstra
- Email: interventieradiologie@vumc.nl
- Phone: +31(0)204444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.