Clinical trial · Interventional
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
NCT00002473CI-TRIAL-00010685completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 specifiedReferences
Publications (4)
- RESULTVan 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 21186077
- RESULTVan 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 17140723
- DERIVEDScosyrev 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 28753863
- DERIVEDScosyrev 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 23850254