Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer - Full Text View

Sponsor:	National Medical Research Council (NMRC), Singapore
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00007930

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

U.S. FDA Resources

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

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

Locations

China
Pamela Youde Nethersole Eastern Hospital	Recruiting
Hong Kong, China
Contact: Michael K.W. Li, FRCS, FHKAM 852-2595-6389 mkwli@ha.org.hk
Hong Kong
Hong Kong Sanatorium & Hospital	Recruiting
Happy Valley, Hong Kong
Contact: Samuel P.Y. Kwok, MD 852-2899-2217 samuelpykwok@gmail.com
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068354, NMRC-ICR01, EU-99019
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00007930 History of Changes
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:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009