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
Recruitment status was Recruiting
Sponsor:
National Medical Research Council (NMRC), Singapore
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007930
First received: January 6, 2001
Last updated: March 8, 2011
Last verified: December 2006
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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 |
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 | |
| 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: | March 8, 2011 |
| 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 May 23, 2013