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

This study has been completed.

First Received: November 1, 1999 Last Updated: February 17, 2009 History of Changes

Sponsor:	European Organization for Research and Treatment of Cancer
Collaborators:	Eastern Cooperative Oncology Group American College of Surgeons Southwest Oncology Group NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002473

Purpose

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.

Condition	Intervention	Phase
Kidney Cancer	Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 1992

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002473

Locations

Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H95 3Y7

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Eastern Cooperative Oncology Group

American College of Surgeons

Southwest Oncology Group

NCIC Clinical Trials Group

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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]

Study ID Numbers:	CDR0000076837, EORTC-30904, ACOSOG-30904, CAN-NCIC-RE1, E-30904, SWOG-EORTC-30904
Study First Received:	November 1, 1999
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00002473 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I renal cell cancer
stage II renal cell cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009