Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Local recurrence at 3 years
Safety Issue:
No
Principal Investigator
Heah Sieu Min, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
Unspecified
Study ID:
CDR0000068354
NCT ID:
NCT00007930
Start Date:
August 1999
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage I rectal cancer
- stage II rectal cancer
- stage III rectal cancer
- Rectal Neoplasms
- Colorectal Neoplasms
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