NCT05883800

Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

Detailed description

This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	On-couch adaptive radiotherapy	A new treatment plan, guided by volumetric images, is created at each treatment session

Timeline

• Start date: 2023-06-22
• Primary completion: 2026-12-31
• Completion: 2031-12-31
• First posted: 2023-06-01
• Last updated: 2024-03-19

Locations

1 site across 1 country: Norway