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
- Study type
- Clinical trial
- Study name
- EORTC 30904
- Phase
- Phase 3
- Design
- Randomised intergroup trial with a noninferiority hypothesis, closed early because of poor accrual
- Sample size
- 541 patients (268 in the nephron-sparing surgery group and 273 in the radical nephrectomy group)
- Source
- European Urology · 2011
- Trial registration
- NCT00002473
In plain words
In this study, patients with a small kidney tumour (up to 5 cm) were randomly assigned either to surgery that removes the tumour while keeping the healthy part of the kidney or to removal of the whole kidney. The cancer results of both approaches were excellent, and few patients died of kidney cancer or had their disease progress. Across all patients, overall survival was slightly better after removal of the whole kidney, but this difference was not significant in patients with confirmed renal cell cancer. The study closed earlier than planned and had fewer patients than intended, so the choice of operation should be made with the treating doctor, based on each patient's situation.
Key results
Treatment arms and regimens
Surgical trial without drug treatment: nephron-sparing surgery (conservative tumour excision) with limited lymph node dissection (268 patients). The tumour had to be in a location where negative surgical margins could be ensured.
Surgical trial without drug treatment: radical nephrectomy with limited lymph node dissection (273 patients).
Source of the regimen details: Surgical trial without drugs; abstract of the paper and ClinicalTrials.gov NCT00002473 (eligibility criteria and intervention plan)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with a solitary T1-T2 renal tumour suspicious for renal cell carcinoma (RCC), maximum diameter 5 cm on CT (UICC 1978 classification), N0 M0, without invasion of the renal pelvis, calyces or perirenal fat (on CT or intravenous urography), in a location where negative surgical margins could be ensured, and with a normal contralateral kidney; WHO performance status 0 to 2; no von Hippel-Lindau disease and no second malignancy (except treated non-melanoma skin cancer) (ClinicalTrials.gov). Enrolment ran from March 1992 to January 2003, and the trial closed early because of low accrual.
Endpoints
The aim of the study was to compare overall survival (OS) and time to progression. Time-to-event data were compared with the log-rank test. Quality of life and renal function were not assessed in this report.
Safety and side effects
The background section of the abstract states that nephron-sparing surgery can be performed safely with a slightly higher complication rate than radical nephrectomy. Detailed adverse event data (grade ≥3) are not reported in the abstract; quality of life and renal function were not assessed either.
Clinical significance and place in guidelines
This randomised trial is one of the few direct comparisons of NSS and RN for small renal tumours. According to the abstract, both approaches had excellent oncological outcomes; however, noninferiority of NSS was not demonstrated (P=0.77), partly because the study closed early due to poor accrual. In the ITT analysis, overall survival was better with RN, but in patients with RCC this difference was not significant, and the small number of deaths from kidney cancer (12) cannot explain the difference. Quality of life and renal function were not assessed. The place of this study in current guidelines should be checked in up-to-date sources.
Limitations
The study closed early because of poor accrual. The number of events (disease progression and death from kidney cancer) was small. Quality of life and renal function outcomes were not assessed. The difference in overall survival in the ITT analysis was not significant in the RCC subgroup or in the other eligible patients. The UICC 1978 staging classification was used.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.