Modified FOLFOXIRI with Target Therapy for Advanced Colorectal Cancer
Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
This study is testing a new way to give chemotherapy for advanced colorectal cancer to see if it works well while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | chemotherapy, Panitumumab, Cetuximab, Bevacizumab |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06575127 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the efficacy and safety of a modified FOLFOXIRI regimen in treating metastatic colorectal cancer (MCRC). The study aims to balance the effectiveness of this chemotherapy with a modified dose to reduce toxicity while maintaining therapeutic benefits. Primary endpoints include assessing the objective response rate and evaluating both acute and delayed toxicity, while secondary endpoints focus on treatment effectiveness as conversion therapy and overall survival. The trial also examines predictive and prognostic factors to enhance treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed unresectable or metastatic colorectal cancer who have measurable disease and an ECOG performance status of 0-1.
Not a fit: Patients with double malignancies, significant peripheral neuropathy, or prior chemotherapy for metastatic colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with advanced colorectal cancer.
How similar studies have performed: Previous studies have shown the efficacy of FOLFOXIRI, but this modified approach aims to address its toxicity, making it a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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
Where this trial is running
Cairo, Cairo Governorate
- Al Hussien University Hospital — Cairo, Cairo Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.