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Home > "K" Clinical Trials Conditions > Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer  Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
For Condition: stage 1 renal cell cancer,stage 2 renal cell cancer,Renal Cell Adenocarcinoma
Status: Completed
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group , Eastern Cooperative Oncology Group,American College of Surgeons,Southwest Oncology Group,National Cancer Institute of Canada
Synopsis: RATIONALE: Kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and may have fewer side effects and improve recovery. It is unknown whether kidney-sparing surgery is more effective than kidney removal in treating kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer.
Details: OBJECTIVES: - Compare time to recurrence and survival of patients with single, low stage, nonmetastatic, well localized, and well delineated renal cell cancer treated with partial vs radical resection. - Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients. - Study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection. - Determine which prognostic factors are important in selecting candidates for conservative surgery. OUTLINE: This is a randomized, multicenter study. Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy (arm I) or conservative surgery (arm II). Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 1300 patients will be accrued for this study over 8 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Single renal T1-2 tumor suspicious for adenocarcinoma that meets the following requirements: - Solitary tumor on CT scan - Maximum diameter 5 cm - Located such that negative resection margins are assured - N0, M0, i.e., no nodal involvement or distant metastases - No invasion of renal pelvis, calices, or perirenal fat as determined by CT scan or intravenous urography - Normal contralateral kidney present - No von Hippel-Lindau disease PATIENT CHARACTERISTICS: Age: - Any age Performance status: - WHO 0-2 Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No second malignancy except adequately treated nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeinPoppel, Study Chair, U.Z. Gasthuisberg
McGill University
Montreal, Quebec, H95 3Y7
Canada
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, M4N 3M5
Canada
Additional Information:
Study ID Numbers: CDR0000076837; EORTC-30904,ACOSOG-30904,CAN-NCIC-RE.1,E-30904,SWOG-EORTC-30904
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002473
Other Stage 2 Renal Cell Cancer Studies:
1. Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
2. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
Related Studies:
Other stage 2 renal cell cancer Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
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