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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070005
First received: October 3, 2003
Last updated: August 6, 2013
Last verified: April 2007
  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
Colorectal Cancer
Perioperative/Postoperative Complications
Procedure: conventional surgery
Procedure: management of therapy complications
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
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
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7300 DS
Reinier de Graaf Group - Delft
Delft, Netherlands, 2625 AD
Albert Schweitzerziekenhuis - Locatie Amstelwijck
Dordrecht NM, Netherlands, NL-3317
Isala Klinieken - locatie Weezenlanden
Zwolle, Netherlands, 8000 GK
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00070005     History of Changes
Other Study ID Numbers: CKTO-2002-02-POCASTER, CDR0000328269, EU-20247
Study First Received: October 3, 2003
Last Updated: August 6, 2013
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

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Colorectal Neoplasms
Postoperative Complications
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014