Rectal Cancer
Conditions
Keywords
sphincter preservation, neoadjuvant therapy
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.
Interventions
RADIATIONHigh-Dose radiotherapy
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.
RADIATIONChemo-radiotherapy
Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* T1 * T4 (proven invasion of sphincter) * Diffuse metastatic syndrome (no curative intent, short expected life span) * preoperative incontinence (non due to the tumor)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sphincter preservation rate | surgery |
Secondary
| Measure | Time frame |
|---|---|
| operative mortality and morbidity | after surgery |
| anatomopathology margins (lateral and inferior) | after surgery |
| Functional results (stoma closure, continence, manometry) | 2 years |
| Tumor response according to rectal endo-echography | prior to surgery |
| Disease-free survival | 3 years |
| Overall Survival | 4 years |
| Local recurrence | 3 years |
Countries
France
Outcome results
None listed