RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

Condition	Treatment or Intervention	Phase
stage I rectal cancer stage II rectal cancer stage III rectal cancer	Procedure: conventional surgery  Procedure: laparoscopic surgery  Procedure: surgery	Phase III

Further Study Details: 

OBJECTIVES:

• Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
• Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
• Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

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

• Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
• Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later. Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

• Clinical diagnosis of rectal cancer by colonoscopy or barium enema
• Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy
• No synchronous multiple adenocarcinomas
• Candidate for low anterior surgical resection by laparoscopy or conventional open method
• No evidence of gross metastatic disease
• No evidence of peritoneal or pelvic metastases

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• At least 6 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Neoadjuvant or adjuvant chemoradiotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy

Surgery:

• See Disease Characteristics

China
      Pamela Youde Nethersole Eastern Hospital, Hong Kong,  China; Recruiting
Hong Kong
      Minimally Invasive and Endoscopic Surgery Centre, Happy Valley,  Hong Kong; Recruiting
Singapore
      National Cancer Centre - Singapore, Singapore,  169608,  Singapore; Recruiting

Study chairs or principal investigators

Heah Sieu Min, MD,  Study Chair,  National Cancer Centre - Singapore   

Study ID Numbers:  CDR0000068354; NMRC-ICR01; EU-99019; NCT00007930
Record last reviewed:  January 2001
Last Updated:  December 6, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007930
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08