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| ID | Type | Description | Link |
|---|---|---|---|
| NMRC-ICR01 | |||
| EU-99019 |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure | |||
| laparoscopic surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free and overall survival at 5 years |
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DISEASE CHARACTERISTICS:
Clinical diagnosis of rectal cancer by colonoscopy or barium enema
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Heah Sieu Min, MD | National Cancer Centre, Singapore | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Sanatorium & Hospital | Recruiting | Hong Kong | China |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Pamela Youde Nethersole Eastern Hospital | Recruiting | Hong Kong | China |
|
| National Cancer Centre - Singapore | Recruiting | Singapore | 169608 | Singapore |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |