Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Medium and Lower Rectal Cancer

Treatments: Procedure: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA); Procedure: Colo-anal anastomosis (CAA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01876901

IB2010-08

Details and patient eligibility

About

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 cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations.

Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%.

An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced.

This study is a multicentre, two arms, phase 2 clinical trial.

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)

Experimental group

Description:

Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.

Treatment:

Procedure: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)

Colo-anal anastomosis (CAA)

Experimental group

Description:

Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Treatment:

Procedure: Colo-anal anastomosis (CAA)