At a glance

ClinicalIndex Comparison Record

Phase 3Recruiting· 360 target

Drug / intervention

Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) +1 moredrug

Likely dose

Not stated in record

Key inclusion· 11

✓Age greater than 18 years
✓Good performance status ECOG 0-2 or ASA 1-3
✓Histologically confirmed primary colorectal tumor
✓Prior local treatment for initial colorectal liver metastases

Key exclusion· 9

✕Extrahepatic disease present
✕Microsatellite instability or deficient mismatch repair status
✕Radical local treatment unfeasible or unsafe due to insufficient future liver volume or other factors
✕Compromised liver function with signs of portal hypertension, INR >1.5 without anticoagulants, or ascites

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05861505

NCT05861505Phase 3RecruitingOn TrackUpdated 37mo ago

Long Recruiting

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

Amsterdam UMC, location VUmc·interventional·Posted May 17, 2023·Updated May 17, 2023

In Brief

A Phase 3 clinical trial evaluating Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) and Repeat local treatment for Colorectal Cancer and 5 related conditions. Currently recruiting, targeting 360 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

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

CountriesNetherlands

Collaborators--

Timeline

Phase 3Recruiting

20242025202620272028

Enrollment StartApr 2023

First PostedMay 2023

TodayJul 2026

Primary CompletionMay 2027

Study CompletionMay 2028

First PostedMay 17, 2023

Enrollment StartApr 24, 2023

Primary CompletionMay 1, 2027

Study CompletionMay 1, 2028

TodayJul 2, 2026

Enrollment to primary: 4.0 yearsPosted 3.1 years agoPrimary completion in 10 months

Interventions

Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)drug

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

Repeat local treatmentother

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).