Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma (GRECCAR1)

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase

Completed

Phase 3

Conditions

Rectal Cancer

Treatments

Radiation: High-Dose radiotherapy

Radiation: Chemo-radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00979680

KBR-2001

Details and patient eligibility

About

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.

Enrollment

207 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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