COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
M Dijkstra
interventieradiologie@vumc.nl
+31(0)204444444
Time Frame
Start Date: 2023-04-24
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 360
Treatments
Active_comparator: Upfront repeat local treatment
Experimental: Neoadjuvant systemic therapy followed by repeat local treatment
Related Therapeutic Areas
Sponsors
Leads: Amsterdam UMC, location VUmc