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Brief Title: Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
Official Title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
Study ID: NCT00979680
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Sainte catherine, Avignon, , France
Hopital Saint Andre, Bordeaux, , France
Hotel Dieu, Clermont-Ferrand, , France
Hopital Michallon, Grenoble, , France
Centre Oscar Lambret, Lille, , France
CAC Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CRLC Val d'Aurelle, Montpellier, , France
Hopital Saint Eloi, Montpellier, , France
Centre Rene Gauducheau, Nantes, , France
Centre Paul Strauss, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Name: Philippe Rouanet, Pr
Affiliation: CRLC Val d'Aurelle
Role: PRINCIPAL_INVESTIGATOR