Status:
COMPLETED
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Lead Sponsor:
Institut Bergonié
Conditions:
Medium and Lower Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Hypothesis: In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon...
Eligibility Criteria
Inclusion
- Histologically proven rectal adenocarcinoma.
- Medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum.
- T1 N+ or T2 N+ or T3 N+ or T3 N0 and M0 tumour.
- Age between 18 and 75 years .
- ASA ≤ 2.
- Sphincter continence compatible with coloanal anastomosis.
- Patients who received preoperative radiotherapy alone or chemotherapy and radiotherapy.
- Patient affiliated to social security.
- For patients of childbearing age, use of contraception.
- Patient information and consent for study participation
Exclusion
- Other histology of rectal cancer.
- T1 N0 or T2 N0 or T4 tumour.
- Metastatic disease M1.
- History of cancer except cervix in situ carcinoma or skin basal cell carcinoma.
- Patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study
- Patients deprived of liberty or under guardianship.
- Pregnant or nursing women.
Key Trial Info
Start Date :
August 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2019
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01876901
Start Date
August 11 2010
End Date
February 14 2019
Last Update
September 4 2025
Active Locations (9)
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1
CHU DE BORDEAUX - Hôpital Saint André
Bordeaux, Aquitaine, France, 33000
2
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
3
CHU de GRENOBLE
Grenoble, Auvergne-Rhône-Alpes, France, 38000
4
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France, 69000