Clinical trial NCT01876901: Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Official title: Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Medium and Lower Rectal Cancer
Keywords: Rectal cancer
Coloanal anastomosis
Phase 2 clinical trial
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA
timeFrame: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.
Secondary outcomes:
measure: Stomata Bypass (Preventive or Therapeutic)
timeFrame: Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA)
measure: Post-operative Morbidity
timeFrame: During the 30 first days after surgery (2SCA or CAA)
measure: Postoperative Mortality
timeFrame: From the date of surgery to 30 days after surgery (2SCA or CAA)
measure: Progression-free Survival
timeFrame: 1 and 2 years after surgery (2SCA or CAA)
measure: Number of Participants With Anal Incontinence at 6 Months
timeFrame: At 6 months after surgery (2SCA or CAA)
measure: Number of Participants With Anal Incontinence at 12 Months
timeFrame: At 12 months after surgery (2SCA or CAA)
measure: Number of Participants With Anal Incontinence at 24 Months
timeFrame: At 24 months after surgery (2SCA or CAA)
measure: Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA
timeFrame: Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU DE BORDEAUX - Hôpital Saint André
state: Aquitaine
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouche Du Rhône
city: Nancy
country: France
facility: Chu de Nancy
state: Lorraine
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
state: Lorraine
city: Grenoble
country: France
facility: CHU de GRENOBLE
state: Rhône Alpes
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône Alpes
city: Villeurbanne
country: France
facility: Clinique Du Tonkin
state: Rhône Alpes
city: Lyon
country: France
facility: HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse
state: Rhône-Alpes
Study officials:
affiliation: Institut Bergonié
name: EVRARD Serge, PU-PH
role: STUDY_CHAIR
References: