Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
Recruiting · NCT06575127 · Interventional (participants receive a specific treatment) · Lead sponsor: Al-Azhar University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
1 location listed.
- Al Hussien University Hospital - Cairo, Cairo Governorate, Egypt