Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

National Medical Research Council (NMRC), Singapore

Status and phase: Unknown; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: conventional surgery; Procedure: laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00007930

EU-99019

NMRC-ICR01

CDR0000068354

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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