Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose of Radiosurgery
研究概览
简要总结
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.
Secondary
- To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
- •Patient is able to give and sign study specific informed consent
- •No prior radiation to the treatment field
- •Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- •Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
- •Karnofsky status of ≥ 60%
- •Signed study-specific informed consent prior to study entry
排除标准
- •Any patient not meeting the eligibility criteria.
- •Any patient with active connective tissue disease such as lupus, dermatomyositis.
- •Any patient with active Crohn's disease or active ulcerative colitis.
- •Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
研究组 & 干预措施
Series 1: Stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
干预措施: stereotactic radiosurgery (Radiation)
Series 1: Stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
干预措施: Renal Biopsy (Procedure)
Series 1: Stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
干预措施: Serum Blood Markers (Procedure)
Series 2: Stereotactic radiosurgery
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
干预措施: stereotactic radiosurgery (Radiation)
Series 2: Stereotactic radiosurgery
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
干预措施: Renal Biopsy (Procedure)
Series 2: Stereotactic radiosurgery
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
干预措施: Serum Blood Markers (Procedure)
结局指标
主要结局
Maximum Tolerated Dose of Radiosurgery
时间窗: once every 4 weeks
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
次要结局
- Progression-free Survival(at 36 months from start of therapy)
- Freedom From Local Progression(at 36 months from start of therapy)
- Freedom to Distant Recurrence(at 36 months from start of therapy)
- Overall Survival(at 36 months from start of therapy)