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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-11

Study Completion Date

2019-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Medium and Lower Rectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two multicenter parallel single-arm phase II trials.

One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.

One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.

After surgical resection, the colon is exteriorized through the anus and attached to the buttock.

By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation

Colo-anal anastomosis (CAA)

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

Group Type EXPERIMENTAL

Colo-anal anastomosis (CAA)

Intervention Type PROCEDURE

After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.

In the absence of fistula, the patient will reoperation for stoma closure of its branch

Interventions

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

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.

After surgical resection, the colon is exteriorized through the anus and attached to the buttock.

By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation

Intervention Type PROCEDURE

Colo-anal anastomosis (CAA)

After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.

In the absence of fistula, the patient will reoperation for stoma closure of its branch

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No