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

Institut du Cancer de Montpellier - Val d'Aurelle12 sites in 1 country207 target enrollmentApril 2001

ConditionsRectal Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Enrollment: 207
Locations: 12
Primary Endpoint: Sphincter preservation rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2001

End Date

September 2007

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Eligibility Criteria

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