Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer

Overview

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.

Full Title of Study: “A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment
  • Study Primary Completion Date: February 2011

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.

Interventions

  • Procedure: conventional surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Organisation for Research and Treatment of Cancer – EORTC
  • Collaborator
    • Eastern Cooperative Oncology Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hein van Poppel, MD, PhD, Study Chair, University Hospital, Gasthuisberg
    • Thomas Keane, MD, Study Chair, Emory University
    • Leonard G. Gomella, MD, Study Chair, Sidney Kimmel Cancer Center at Thomas Jefferson University
    • Eila C. Skinner, MD, Study Chair, University of Southern California
    • Laurence H. Klotz, MD, Study Chair, Toronto Sunnybrook Regional Cancer Centre

Citations Reporting on Results

Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Colombel M, Klotz L, Skinner E, Keane T, Marreaud S, Collette S, Sylvester R. A prospective, randomised EORTC intergroup phase 3 study comparing the oncologic outcome of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma. Eur Urol. 2011 Apr;59(4):543-52. doi: 10.1016/j.eururo.2010.12.013. Epub 2010 Dec 22.

Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Marechal JM, Klotz L, Skinner E, Keane T, Claessens I, Sylvester R; European Organization for Research and Treatment of Cancer (EORTC); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Southwest Oncology Group (SWOG); Eastern Cooperative Oncology Group (ECOG). A prospective randomized EORTC intergroup phase 3 study comparing the complications of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma. Eur Urol. 2007 Jun;51(6):1606-15. doi: 10.1016/j.eururo.2006.11.013. Epub 2006 Nov 15.

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