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OncoMatch/Clinical Trials/NCT06575127

Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study

Is NCT06575127 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FOLFOXIRI Protocol for neoplasm malignant.

Phase 2RecruitingAl-Azhar UniversityNCT06575127Data as of May 2026

Treatment: FOLFOXIRI ProtocolThis prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. . The primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance. This study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: DPYD mutation

Disease stage

Required: Stage UNRESPECTABLE, IV

Metastatic disease required

Histologically confirmed unrespectable or metastatic colorectal cancer with or without primary tumor in situ.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Exception: adjuvant/neoadjuvant therapy not in metastatic setting

Prior exposure to chemotherapy treatment for colorectal cancer in the metastatic setting

Lab requirements

Blood counts

adequate baseline hematology

Cardiac function

adequate cardiac function

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

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