NCT00002473

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1992

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

18.9 years

First QC Date

November 1, 1999

Last Update Submit

June 11, 2013

Conditions

Kidney Cancer

Keywords

stage I renal cell cancerstage II renal cell cancer

Interventions

conventional surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook and Women's College Health Sciences Centre

North York, Ontario, M4N 3M5, Canada

Location

McGill University

Montreal, Quebec, H95 3Y7, Canada

Location

Related Publications (4)

  • 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.

    PMID: 21186077RESULT

  • 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.

    PMID: 17140723RESULT

  • 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.

    PMID: 28753863DERIVED

  • 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.

    PMID: 23850254DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Hein van Poppel, MD, PhD

    University Hospital, Gasthuisberg

    STUDY CHAIR

  • Thomas Keane, MD

    Emory University

    STUDY CHAIR

  • Leonard G. Gomella, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    STUDY CHAIR

  • Eila C. Skinner, MD

    University of Southern California

    STUDY CHAIR

  • Laurence H. Klotz, MD

    Toronto Sunnybrook Regional Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1992

Primary Completion

February 1, 2011

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

CA(2)