NCT05253846

Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29

Phase II Study of Short-course Radiotherapy Followed by Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: the ShorTrip Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.

Detailed description

This is a prospective, open-label, multicentre, phase II single arm trial. Eligible patients with middle-high LARC will receive short-course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery. The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	chemotherapy treatment
DRUG	Oxaliplatin	chemotherapy treatment
DRUG	Lederfolin	treatment
DRUG	5-Fluorouracil	chemotherapy treatment
RADIATION	Short-course radiotherapy	RT
PROCEDURE	TME	surgery

Timeline

• Start date: 2022-01-25
• Primary completion: 2025-01-05
• Completion: 2028-10-30
• First posted: 2022-02-24
• Last updated: 2025-06-10

Locations

1 site across 1 country: Italy