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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Colorectal Cancer	Procedure: conventional surgery Procedure: management of therapy complications	Phase III

MedlinePlus related topics:

Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Functional outcome as measured by a validated questionnaire

Secondary Outcome Measures:

Quality life as measured by a validated questionnaire
Anorectal function as assessed by anorectal manometry and barostat measurements

Estimated Enrollment:	100
Study Start Date:	June 2002

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070005

Locations


Netherlands
	Academisch Medisch Centrum at University of Amsterdam
	Amsterdam, Netherlands, 1105 AZ
	Albert Schweitzerziekenhuis - Locatie Amstelwijck
	Dordrecht NM, Netherlands, NL-3317
	Gelre Ziekenhuizen - Lokatie Lukas
	Apeldoorn, Netherlands, 7300 DS
	Isala Klinieken - locatie Weezenlanden
	Zwolle, Netherlands, 8000 GK
	St. Lucas - Andreas Ziekenhuis
	Amsterdam, Netherlands, 1091 AE
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
	Amsterdam, Netherlands, 1066 CX
	Onze Lieve Vrouwe Gasthuis
	Amsterdam, Netherlands, 1091 HA
	Reinier de Graaf Group - Delft
	Delft, Netherlands, 2625 AD
	Isala Klinieken - locatie Sophia
	Zwolle, Netherlands, 8000 GK

Sponsors and Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators


Study Chair:	Roel Bakx, MD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000328269, CKTO-2002-02-POCASTER, EU-20247
First Received:	October 3, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00070005
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

perioperative/postoperative complications

stage I rectal cancer

stage II rectal cancer

stage III rectal cancer

adenocarcinoma of the rectum

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Rectal neoplasm

Carcinoma

Digestive System Diseases

Postoperative Complications

Gastrointestinal Neoplasms

Adenocarcinoma

Rectal cancer

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00070005