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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007930
First received: January 6, 2001
Last updated: August 23, 2013
Last verified: December 2006
  Purpose

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 Intervention Phase
Colorectal Cancer
Procedure: conventional surgery
Procedure: laparoscopic surgery
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local recurrence at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free and overall survival at 5 years [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: August 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007930

Locations
China
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, China
Contact: Samuel P.Y. Kwok, MD    852-2899-2217    samuelpykwok@gmail.com   
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Michael K.W. Li, FRCS, FHKAM    852-2595-6389    mkwli@ha.org.hk   
Singapore
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169608
Contact: Heah Sieu Min, MD    65-6526-5247      
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
Investigators
Study Chair: Heah Sieu Min, MD National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00007930     History of Changes
Other Study ID Numbers: CDR0000068354, NMRC-ICR01, EU-99019
Study First Received: January 6, 2001
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on July 26, 2014