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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.
Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.
Institut Sainte catherine
Avignon, France
Hopital Saint Andre
Bordeaux, France
Hotel Dieu
Clermont-Ferrand, France
Hopital Michallon
Grenoble, France
Sphincter preservation rate
Time frame: surgery
Tumor response according to rectal endo-echography
Time frame: prior to surgery
operative mortality and morbidity
Time frame: after surgery
anatomopathology margins (lateral and inferior)
Time frame: after surgery
Functional results (stoma closure, continence, manometry)
Time frame: 2 years
Local recurrence
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Overall Survival
Time frame: 4 years
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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
...and 2 more locations