Actively Recruiting
Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
Led by Al-Azhar University · Updated on 2024-08-28
60
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable or metastatic colorectal cancer with or without primary tumor in place
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate baseline blood counts and chemistry tests
- Adequate heart function
You will not qualify if you...
- History of two or more primary cancers (double malignancy)
- Presence of DPYD gene mutation
- Peripheral neuropathy grade 3 or higher from other health issues
- Chronic gastrointestinal diseases such as inflammatory bowel syndrome
- Prior chemotherapy for metastatic colorectal cancer
- Contraindications to any drugs used in the study regimen
AI-Screening
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Trial Site Locations
Total: 1 location
1
Al Hussien University Hospital
Cairo, Cairo Governorate, Egypt, 11311
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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