Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed Any age Other EORTC-30904 ACOSOG-30904, CAN-NCIC-RE1, E-30904, SWOG-EORTC-30904, NCT00002473, RE1

Objectives

1. 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.
2. Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients.
3. Study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection.
4. Determine which prognostic factors are important in selecting candidates for conservative surgery.

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

A total of 1300 patients will be accrued for this study over 8 years.

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.

Van Poppel H, Da Pozzo L, Albrecht W, et al.: 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 51 (6): 1606-15, 2007.[PUBMED Abstract]

Bohle A: 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. Int Braz J Urol 34 (3): 389, 2008 May-Jun.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Hein van Poppel, MD, PhD, Protocol chair		Ph: 32-1634-6687 Email: hendrik.vanpoppel@uz.kuleuven.ac.be

Eastern Cooperative Oncology Group

Thomas Keane, MD, Protocol chair(Contact information may not be current)		Ph: 404-778-5180; 888-946-7447

American College of Surgeons Oncology Group

Leonard Gomella, MD, Protocol chair		Ph: 215-955-6963; 800-533-3669

Southwest Oncology Group

Eila Skinner, MD, Protocol chair		Ph: 323-865-3705; 800-865-0102 Email: skinner@hsc.usc.edu

NCIC-Clinical Trials Group

Laurence Klotz, MD, Protocol chair		Ph: 416-480-5000

Registry Information
Official Title		A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
Trial Start Date		1992-03-30
Registered in ClinicalTrials.gov		NCT00002473
Date Submitted to PDQ		1992-03-30
Information Last Verified		2002-07-31
NCI Grant/Contract Number		CA11488

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