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

NCT ID: NCT00002473

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-03-31

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

American College of Surgeons

OTHER

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hein van Poppel, MD, PhD

Role: STUDY_CHAIR

University Hospital, Gasthuisberg

Thomas Keane, MD

Role: STUDY_CHAIR

Emory University

Leonard G. Gomella, MD

Role: STUDY_CHAIR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eila C. Skinner, MD

Role: STUDY_CHAIR

University of Southern California

Laurence H. Klotz, MD

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Locations

Sunnybrook and Women's College Health Sciences Centre

North York, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 21186077 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17140723 (View on PubMed)

Scosyrev E, Messing EM, Sylvester R, Van Poppel H. Exploratory Subgroup Analyses of Renal Function and Overall Survival in European Organization for Research and Treatment of Cancer randomized trial of Nephron-sparing Surgery Versus Radical Nephrectomy. Eur Urol Focus. 2017 Dec;3(6):599-605. doi: 10.1016/j.euf.2017.02.015. Epub 2017 Apr 4.

Reference Type: DERIVED

PMID: 28753863 (View on PubMed)

Scosyrev E, Messing EM, Sylvester R, Campbell S, Van Poppel H. Renal function after nephron-sparing surgery versus radical nephrectomy: results from EORTC randomized trial 30904. Eur Urol. 2014 Feb;65(2):372-7. doi: 10.1016/j.eururo.2013.06.044. Epub 2013 Jul 2.

Reference Type: DERIVED

PMID: 23850254 (View on PubMed)

Other Identifiers

EORTC-30904

Identifier Type: -

Identifier Source: secondary_id

ACOSOG-30904

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-RE1

Identifier Type: -

Identifier Source: secondary_id

E-30904

Identifier Type: -

Identifier Source: secondary_id

SWOG-EORTC-30904

Identifier Type: -

Identifier Source: secondary_id

EORTC-30904

Identifier Type: -

Identifier Source: org_study_id