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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 17, 2009

Start Date ^ICMJE

March 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Procedure: conventional surgery

Study Arms / Comparison Groups

Publications *

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; for the European Organization for Research and Treatment of Cancer (EORTC); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Southwest Oncology Group (SWOG); the 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. 2006 Nov 15; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00002473

Responsible Party

Study ID Numbers ^ICMJE

CDR0000076837, EORTC-30904, ACOSOG-30904, CAN-NCIC-RE1, E-30904, SWOG-EORTC-30904

Study Sponsor ^ICMJE

European Organization for Research and Treatment of Cancer

Collaborators ^ICMJE

Eastern Cooperative Oncology Group
American College of Surgeons
Southwest Oncology Group
NCIC Clinical Trials Group

Investigators ^ICMJE

Study Chair:	Hein van Poppel, MD, PhD	U.Z. Gasthuisberg
Study Chair:	Thomas Keane, MD	Emory University
Study Chair:	Leonard G. Gomella, MD	Kimmel Cancer Center (KCC)
Study Chair:	Eila C. Skinner, MD	USC/Norris Comprehensive Cancer Center
Study Chair:	Laurence H. Klotz, MD	Edmond Odette Cancer Centre at Sunnybrook

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP