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 anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

PURPOSE: Randomized phase III trial to compare the effectiveness of J-pouch coloanal anastomosis with that of side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

Condition	Treatment or Intervention	Phase
perioperative/postoperative complications stage I rectal cancer stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum	Procedure: complications of therapy assessment/management  Procedure: conventional surgery  Procedure: supportive care/therapy  Procedure: surgery	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
      Albert Schweitzerziekenhuis - Locatie Amstelwijck, Dordrecht NM,  NL-3317,  Netherlands; Recruiting
      Gelre Ziekenhuizen - Lokatie Lukas, Apeldoorn,  7334 DZ,  Netherlands; Recruiting
      Isala Klinieken - locatie Weezenlanden, Zwolle,  NL-8000 GM,  Netherlands; Recruiting
      Isala Klinieken - locatie Sophia, Zwolle,  8000 GK,  Netherlands; Recruiting
      Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands; Recruiting
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands; Recruiting
      Reinier de Graaf Group - Delft, Delft,  2625 AD,  Netherlands; Recruiting
      St. Lucas - Andreas Ziekenhuis, Amsterdam,  1091 AE,  Netherlands; Recruiting

Study chairs or principal investigators

Roel Bakx, MD,  Study Chair,  Academisch Medisch Centrum   

Study ID Numbers:  CDR0000328269; CKTO-2002-02-POCASTER; EU-20247; NCT00070005
Record last reviewed:  January 2004
Last Updated:  April 5, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070005
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08