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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00007930
• Other study ID #: CDR0000068354
• Secondary ID: NMRC-ICR01EU-990
• Status: Recruiting
• Phase: Phase 3
• First received: January 6, 2001
• Last updated: August 23, 2013
• Start date: August 1999

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• conventional surgery

• laparoscopic surgery

Locations

Country	Name	City	State
China	Hong Kong Sanatorium & Hospital	Hong Kong
China	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Singapore	National Cancer Centre - Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Council (NMRC), Singapore

Countries where clinical trial is conducted

China,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence at 3 years			No
Secondary	Disease-free and overall survival at 5 years			No