RecruitingPhase 2NCT06575127

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

Sponsor

Al-Azhar University

Enrollment

60 participants

Start Date

Aug 17, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasm Malignant Colon Cancer Stage 4

Summary

This 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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests an intensive combination chemotherapy regimen (modified FOLFOXIRI) together with targeted therapy as a first-line treatment for people with advanced (unresectable or metastatic) colorectal cancer. It is a phase 2 trial to see how well this combination works. **You may be eligible if...** - You have been diagnosed with unresectable or metastatic colorectal cancer confirmed by biopsy - You have at least one measurable tumor on imaging - Your performance status is ECOG 0–1 - Your heart, blood counts, and other organ functions are within acceptable ranges - You have not received prior chemotherapy for metastatic colorectal cancer **You may NOT be eligible if...** - You have a second cancer - You have a DPYD gene mutation (increases risk of serious chemotherapy side effects) - You have serious pre-existing nerve damage, inflammatory bowel disease, or other chronic gut conditions - You have had prior chemo for metastatic colorectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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