NCT05354817

Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

Re-Play: Impact of FOLFIRINOX Chemotherapy in IV Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS. Currently at ICESP, patients are frequently re-exposed in third line to double combinations.

Detailed description

Single-arm phase II study. The chemotherapy regimen with mFOLFIRINOX will be administered every 14 for 4 cycles, after evaluation of tumor response, you can maintain treatment until disease progression. The FOLFIRINOX regimen, as well as the drugs used (oxaliplatin, 5-Fluorouracil, leucovorin and irinotecan) is already indicated in the package insert for the treatment of colorectal cancer. If treatment is discontinued after cycle 4 with the patient responding, for response maximum or unmanageable toxicity, it is suggested to maintain imaging control every 60 days (7-day window) until disease progression. This interval is already commonly used for patients with metastatic disease who are on treatment pause. Treatment in progression of illness will be at the discretion of the treating physician. Cancer patients undergoing chemotherapy routinely perform evaluation of organ functions and CEA, as well as clinical evaluation before each cycle of treatment

Conditions

• Colorectal Cancer Stage IV

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX	mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: Brazil