NCT05622357

Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are: * Is total neoadjuvant treatment in this design safe \& tolerable? * Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

Detailed description

Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Conditions

• Locally Advanced Rectal Carcinoma

Interventions

Type	Name	Description
RADIATION	short course radiation therapy followed by 6 cycles of CAPOX then surgery	Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

Timeline

• Start date: 2018-03-18
• Primary completion: 2020-12-20
• Completion: 2021-09-01
• First posted: 2022-11-18
• Last updated: 2022-11-18

Locations

1 site across 1 country: Egypt