Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rectal Cancer
Both
Rectal Cancer
Trial Information
Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Sphincter preservation rate
Outcome Time Frame:
surgery
Safety Issue:
No
Principal Investigator
Philippe Rouanet, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
CRLC Val d'Aurelle
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
KBR-2001
NCT ID:
NCT00979680
Start Date:
April 2001
Completion Date:
September 2007
Related Keywords:
- Rectal Cancer
- sphincter preservation
- neoadjuvant therapy
- Rectal Neoplasms
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