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RECRUITING
NCT06575127
PHASE2

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

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-08-17

Completion Date

2026-09-01

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DRUG

FOLFOXIRI Protocol

as mentioned in Arm description

Locations (1)

Al Hussien University Hospital

Cairo, Cairo Governorate, Egypt