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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Egypt
Al Hussien University Hospital
RECRUITING
Cairo
Time Frame
Start Date: 2024-08-17
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 60
Treatments
Experimental: modified FOLFOXIRI plus target therapy
* Pre-Treatment Medications:~ 1. Atropine SC: Administered before irinotecan infusion to prevent side effects.~ 2. High-Risk Anti-Emetics Regimen: Used to prevent acute and delayed vomiting.~* Chemotherapy Regimen: All eligible patients will receive the modified FOLFOXIRI regimen as follows:~ * Oxaliplatin: 85 mg/m² IV over 2 hours (Day 1)~ * Irinotecan: 150 mg/m² IV over 90 minutes (Day 1)~ * 5-FU: 2400 mg/m² IV over 48 hours infusion (Days 1)~* Targeted Therapy: Administered according to NRAS/KRAS status and the location of the primary tumor:~ * KRAS/NRAS/BRAF Wild-Type (Left-Sided Tumor): Anti-EGFR treatment with either Panitumumab (6 mg/kg over 60 minutes, Day 1) or Cetuximab (500 mg/m², Day 1).~ * KRAS/NRAS Mutant or Right-Sided Tumor: Bevacizumab at a dose of 5 mg/kg IV over 30 to 90 minutes (Day 1).~* Treatment Schedule: The treatment will be administered biweekly for a maximum of 12 cycles (6 months).
Related Therapeutic Areas
Sponsors
Leads: Al-Azhar University

This content was sourced from clinicaltrials.gov