Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	Over 18	Other	CKTO-2002-02-POCASTER EU-20247, NCT00070005

Objectives

Primary

1. 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

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

Entry 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

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

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

Expected Enrollment

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

Outcomes

Functional outcome as measured by a validated questionnaire

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

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.

Trial Contact Information

Trial Lead Organizations

Academisch Medisch Centrum at University of Amsterdam

Roel Bakx, MD, Protocol chair		Ph: 31-20-566-3405

Registry Information
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
Trial Start Date		2002-06-01
Registered in ClinicalTrials.gov		NCT00070005
Date Submitted to PDQ		2003-08-11
Information Last Verified		2007-04-10

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