Clinical trial NCT00002473: Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
Official title: A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Cancer
Keywords: stage I renal cell cancer
stage II renal cell cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Eastern Cooperative Oncology Group
name: American College of Surgeons
name: SWOG Cancer Research Network
name: NCIC Clinical Trials Group
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: Sunnybrook and Women's College Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: University Hospital, Gasthuisberg
name: Hein van Poppel, MD, PhD
role: STUDY_CHAIR
affiliation: Emory University
name: Thomas Keane, MD
role: STUDY_CHAIR
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Leonard G. Gomella, MD
role: STUDY_CHAIR
affiliation: University of Southern California
name: Eila C. Skinner, MD
role: STUDY_CHAIR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Laurence H. Klotz, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.