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Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
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.
Age
18 - No limit years
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
Start Date
April 1, 2001
Completion Date
September 1, 2007
Last Updated
June 29, 2023
207
ACTUAL participants
High-Dose radiotherapy
RADIATION
Chemo-radiotherapy
RADIATION
Lead Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT04704661
NCT06696768
Data Source & Attribution
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