Clinical trial NCT00070005: J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
Official title: A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Perioperative/Postoperative Complications
Keywords: perioperative/postoperative complications
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

Detailed description: OBJECTIVES:

Primary

* Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.

Secondary

* Compare the quality of life of patients treated with these procedures.
* Compare anorectal function in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.
* Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.

In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks.

Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.

PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the rectum

  * T2 or T3 disease
* Disease located in the mid- or distal rectum
* No evidence of metastatic disease
* No preexisting grade III or IV incontinence
* Completed preoperative radiotherapy (5 x 5 Gy) before study entry

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Working knowledge of the Dutch language

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No prior radiotherapy to the pelvis

Surgery

* No prior colon resection
* No prior anorectal surgery
* No concurrent abdominoperineal resection

Primary outcomes:
measure: Functional outcome as measured by a validated questionnaire
Secondary outcomes:
measure: Quality life as measured by a validated questionnaire
measure: Anorectal function as assessed by anorectal manometry and barostat measurements
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Amsterdam
country: Netherlands
facility: St. Lucas - Andreas Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum at University of Amsterdam
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen - Lokatie Lukas
city: Delft
country: Netherlands
facility: Reinier de Graaf Group - Delft
city: Dordrecht NM
country: Netherlands
facility: Albert Schweitzerziekenhuis - Locatie Amstelwijck
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Sophia
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Weezenlanden
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Roel Bakx, MD
role: STUDY_CHAIR
References: