Spots Global Cancer Trial Database for Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
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Trial Identification
Brief Title: Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
Official Title: A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
Study ID: NCT00002473
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sunnybrook and Women's College Health Sciences Centre, North York, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Contact Details
Name: Hein van Poppel, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR
Name: Thomas Keane, MD
Affiliation: Emory University
Role: STUDY_CHAIR
Name: Leonard G. Gomella, MD
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Role: STUDY_CHAIR
Name: Eila C. Skinner, MD
Affiliation: University of Southern California
Role: STUDY_CHAIR
Name: Laurence H. Klotz, MD
Affiliation: Toronto Sunnybrook Regional Cancer Centre
Role: STUDY_CHAIR
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