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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-30904 | |||
| ACOSOG-30904 | |||
| CAN-NCIC-RE1 | |||
| E-30904 | |||
| SWOG-EORTC-30904 |
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| Name | Class |
|---|---|
| Eastern Cooperative Oncology Group | NETWORK |
| American College of Surgeons | OTHER |
| SWOG Cancer Research Network | NETWORK |
| NCIC Clinical Trials Group |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure |
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
Normal contralateral kidney present
No von Hippel-Lindau disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Hein van Poppel, MD, PhD | University Hospital, Gasthuisberg | Study Chair |
| Thomas Keane, MD | Emory University | Study Chair |
| Leonard G. Gomella, MD | Sidney Kimmel Comprehensive 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook and Women's College Health Sciences Centre | North York | Ontario | M4N 3M5 | Canada | ||
| McGill University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21186077 | Result | 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. | |
| 17140723 |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| NETWORK |
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| Montreal |
| Quebec |
| H95 3Y7 |
| Canada |
| Result |
| 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. |
| 28753863 | Derived | 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. |
| 23850254 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |