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

Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: conventional surgery; Procedure: laparoscopic surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Pamela Youde Nethersole Eastern Hospital
    • Contact: Michael K.W. Li, FRCS, FHKAM; Phone Number: 852-2595-6389; Email: mkwli@ha.org.hk
  • Hong Kong, China
    • Recruiting
    • Hong Kong Sanatorium & Hospital
    • Contact: Samuel P.Y. Kwok, MD; Phone Number: 852-2899-2217; Email: samuelpykwok@gmail.com
• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • National Cancer Centre - Singapore
    • Contact: Heah Sieu Min, MD; Phone Number: 65-6526-5247

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local recurrence at 3 years

Secondary Outcome Measures

Outcome Measure
Disease-free and overall survival at 5 years

Collaborators and Investigators

• Sponsor: National Medical Research Council (NMRC), Singapore
• Investigators: Study Chair: Heah Sieu Min, MD, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start: August 1, 1999

Study Registration Dates

• First Submitted: January 6, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Keywords: stage II rectal cancer; stage III rectal cancer; stage I rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CDR0000068354; NMRC-ICR01; EU-99019