NCT06812728

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.

Detailed description

This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.

Conditions

• Rectum Cancer

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX	Neoadjuvant chemotherapy
DRUG	mFolfox6	Neoadjuvant chemotherapy

Timeline

• Start date: 2025-01-25
• Primary completion: 2027-01-25
• Completion: 2027-02-25
• First posted: 2025-02-06
• Last updated: 2025-02-19

Locations

1 site across 1 country: Egypt