Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).

Trial Details

NCT ID
NCT05008809
Phase
PHASE3
Sponsor
Dominik Paul Modest
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • mFOLFOX6
  • mFOLFOXIRI
  • FOLFIRI
  • CAPOX
Locations (sample)
  • Amberg, Germany|49.44287,11.86267
  • Bad Saarow, Germany|52.28333,14.06667
  • Bayreuth, Germany|49.94782,11.57893
  • Berlin, Germany|52.52437,13.41053
  • Berlin, Germany|52.52437,13.41053

Key Eligibility Criteria

  • Patient's signed informed consent.
  • Patient's age ≥18 years at the time of signing the informed consent.
  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization (ear…

For full eligibility, visit ClinicalTrials.gov.

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