A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
N/A
N/A
Both
Kidney Cancer
Trial Information
A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Hein van Poppel, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
U.Z. Gasthuisberg
Authority:
United States: Federal Government
Study ID:
EORTC-30904
NCT ID:
NCT00002473
Start Date:
March 1992
Completion Date:
Related Keywords:
- Kidney Cancer
- stage I renal cell cancer
- stage II renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|
