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OncoMatch/Clinical Trials/NCT05008809

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

Is NCT05008809 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including mFOLFOX6 and mFOLFOXIRI for colorectal cancer.

Phase 3RecruitingDominik Paul ModestNCT05008809Data as of May 2026

Treatment: mFOLFOX6 · mFOLFOXIRI · FOLFIRI · CAPOXThis 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).

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Metastatic disease required

Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization ... AND resected primary tumor (synchronous or metachronous)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1.5 x 10^9/L (1500/µL); Hemoglobin ≥ 80 g/L (8 g/dL); Platelet count ≥ 100 x10^9/L (100000/µL) without transfusion

Kidney function

Calculated GFR ≥ 50 mL/min or serum creatinine ≤ 1.5 x ULN

Liver function

Total serum bilirubin of ≤ 1.5 x ULN; AST/GOT ≤ 3.0 × ULN

Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results: ... [see above]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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