Status:
COMPLETED
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Patient...
Eligibility Criteria
Inclusion
- 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
- T1
- T4 (proven invasion of sphincter)
- Diffuse metastatic syndrome (no curative intent, short expected life span)
- preoperative incontinence (non due to the tumor)
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00979680
Start Date
April 1 2001
End Date
September 1 2007
Last Update
June 29 2023
Active Locations (12)
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1
Institut Sainte catherine
Avignon, France
2
Hopital Saint Andre
Bordeaux, France
3
Hotel Dieu
Clermont-Ferrand, France
4
Hopital Michallon
Grenoble, France