Status:
RECRUITING
Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
Lead Sponsor:
Al-Azhar University
Conditions:
Neoplasm Malignant
Colon Cancer Stage 4
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This prospective Phase II clinical trial aims to assess the efficacy and safety of a modified dose regimen of FOLFOXIRI in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI is a chemothe...
Eligibility Criteria
Inclusion
- Histologically confirmed unrespectable or metastatic colorectal cancer with or without primary tumor in situ.
- Patients were required to have measurable disease according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (Eisenhauer EA,2009)
- ECOG PS 0-1 better to exclude PS II as this protocol is known to be toxic
- Adequate baseline hematology and clinical chemistry labs
- Adequate cardiac function
Exclusion
- Double Malignancy
- DPYD mutant patients
- Peripheral neuropathy grade 3 or higher patient due to other comorbidities
- Inflammatory bowel syndrome or any other chronic GIT disease
- Prior exposure to chemotherapy treatment for colorectal cancer in the metastatic setting
- Patients who have contraindications for one or more of the study protocol drugs
Key Trial Info
Start Date :
August 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06575127
Start Date
August 17 2024
End Date
September 1 2026
Last Update
August 28 2024
Active Locations (1)
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1
Al Hussien University Hospital
Cairo, Cairo Governorate, Egypt, 11311