NCT00979680

Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	High-Dose radiotherapy	Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.
RADIATION	Chemo-radiotherapy	Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Timeline

• Start date: 2001-04-01
• Completion: 2007-09-01
• First posted: 2009-09-18
• Last updated: 2023-06-29

Locations

12 sites across 1 country: France