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

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Radiation: Chemo-radiotherapy; Radiation: High-Dose radiotherapy

• Registration Number: NCT00979680
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study Completion: 2007-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
• Tumor classified as EER UT2-UT3, whatever the nodal status
• pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
• Age 18 years or older
• Informed and written consent

Exclusion Criteria

• T1
• T4 (proven invasion of sphincter)
• Diffuse metastatic syndrome (no curative intent, short expected life span)
• preoperative incontinence (non due to the tumor)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemo-radiotherapy	Chemo-radiotherapy	-
High-dose Radiotherapy	High-Dose radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Sphincter preservation rate	surgery

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3 years
Overall Survival	4 years
Tumor response according to rectal endo-echography	prior to surgery
operative mortality and morbidity	after surgery
anatomopathology margins (lateral and inferior)	after surgery
Functional results (stoma closure, continence, manometry)	2 years
Local recurrence	3 years

Trial Locations

Locations (12)

Hotel Dieu; 🇫🇷 Clermont-Ferrand, France

Institut Sainte catherine; 🇫🇷 Avignon, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital Michallon; 🇫🇷 Grenoble, France

CRLC Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

CAC Léon Bérard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Rene Gauducheau; 🇫🇷 Nantes, France

Hopital Saint Eloi; 🇫🇷 Montpellier, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France