A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •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
- •Not specified
排除标准
- 未提供