Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05861505

COLLISION RELAPSE Trial

Led by Amsterdam UMC, location VUmc · Updated on 2023-05-17

360

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

COLLISION RELAPSE Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Good performance status (ECOG 0-2 or ASA 1-3)
  • Histological confirmation of primary colorectal cancer
  • Previous local treatment performed for initial colorectal liver metastases
  • New recurrence detected within 12 months
  • At least 1 locally treatable colorectal liver metastasis (resectable and/or ablatable)
  • Total number of new colorectal liver metastases 5 or fewer
  • Chemotherapy-nafve or prior response to CAPOX, FOLFOX, or FOLFIRI chemotherapy
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and kidney function
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Presence of cancer outside the liver (extrahepatic disease)
  • Microsatellite instability or deficient mismatch repair (MSI/dMMR)
  • Repeat local treatment not feasible or unsafe (e.g., insufficient future liver volume)
  • Poor liver function (signs of portal hypertension, INR > 1.5 without anticoagulants, ascites)
  • Uncontrolled infections above grade 2 severity
  • Pregnant or breastfeeding
  • Immunotherapy or chemotherapy within 6 weeks before randomization
  • Severe allergy to contrast media not controlled by premedication
  • Substance abuse or medical, psychological, or social conditions interfering with study participation or evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

M

M Dijkstra

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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