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| Descriptive Information Fields | |||||
| Brief Title † | Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer | ||||
| Official Title † | Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer | ||||
| Brief Summary | RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer. PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients undergo laparoscopic surgery or conventional open surgery. Patients are followed at 1 and 3 months following surgery, then every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within 5 years. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Colorectal Cancer | ||||
| Intervention † | Procedure: conventional surgery Procedure: laparoscopic surgery |
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| MEDLINE PMIDs | 15894098, 15997446, 17634484 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 1200 | ||||
| Start Date † | July 1996 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003354 | ||||
| Organization ID | CDR0000066336 | ||||
| Secondary IDs †† | MRC-CLASICC, NYCTRU-CLASICC, EU-98014, ISRCTN74883561 | ||||
| Study Sponsor † | Medical Research Council | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2001 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||