Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
18 Years
75 Years
Both
Medium and Lower Rectal Cancer
Trial Information
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Main objective is to evaluate effectiveness of delayed coloanal anastomosis (ACAD) in the medium and lower rectal cancer treatment,
Outcome Description:
The primary endpoint was the effectiveness of the ACAD surgery evaluated in terms of absence of fistula requiring stoma diversion. We wish to highlight that the rate of patients with a fistula requiring stoma diversion is less than 15%, that is to say that the effectiveness of the ACAD rate is higher than 85%. Based on a one-sided binomial test with the null and alternative hypotheses respectively 85% 95% 53 ACAD eligible and evaluable patients will be required (one-sided type I error of 5% and 80% power). If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the ACAD is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients ACAD.
Outcome Time Frame:
Delayed coloanal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation
Safety Issue:
Yes
Principal Investigator
EVRARD Serge, PU-PH
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
FRANCE : French Agency for Sanitary Safety of Health Products
Study ID:
IB2010-08
NCT ID:
NCT01876901
Start Date:
May 2010
Completion Date:
May 2016
Related Keywords:
- Medium and Lower Rectal Cancer
- Rectal cancer
- Coloanal anastomosis
- Phase 2 clinical trial
- Rectal Neoplasms
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