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

NCT ID: NCT00007930

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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stage I rectal cancer stage II rectal cancer stage III rectal cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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conventional surgery

Intervention Type PROCEDURE

laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Heah Sieu Min, MD

Role: STUDY_CHAIR

National Cancer Centre, Singapore

Locations

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Hong Kong Sanatorium & Hospital

Hong Kong, , China

Site Status RECRUITING

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , China

Site Status RECRUITING

National Cancer Centre - Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

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Hong Kong China Singapore

Facility Contacts

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Samuel P.Y. Kwok, MD

Role: primary

Michael K.W. Li, FRCS, FHKAM

Role: primary

Heah Sieu Min, MD

Role: primary

Other Identifiers

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NMRC-ICR01

Identifier Type: -

Identifier Source: secondary_id

EU-99019

Identifier Type: -

Identifier Source: secondary_id

CDR0000068354

Identifier Type: -

Identifier Source: org_study_id