A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose for up to 90 days after completion of study treatment
研究概览
简要总结
RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in patients with isolated tumors. (Phase I)
- Determine the minimum dose required for local control. (Phase II)
Secondary
- Determine the radiographic response rate.
- Determine the median time to progression of the treated tumor.
- Evaluate the toxicity of treatment.
- Evaluate the cause of death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI
- •Maximum diameter of 6 cm
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 3 months
- •Not pregnant
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •Must be able to tolerate CT scan or MRI contrast
- •PRIOR CONCURRENT THERAPY:
- •At least 3 weeks since prior chemotherapy or immunotherapy
- •No prior treatment on this study
- •No chemotherapy or immunotherapy during and for 4 weeks after completion of study treatment
- •No concurrent external-beam radiotherapy overlapping with the radiosurgically-treated volume (including low-dose regions)
排除标准
- 未提供
研究组 & 干预措施
Single fractionated radiation adjusted for tumor size
Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line
干预措施: Radiosurgery (Procedure)
结局指标
主要结局
Maximum tolerated dose for up to 90 days after completion of study treatment
时间窗: day 1 through 90
Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment
时间窗: day 1 through 90
次要结局
- Median time to progression of treated tumor for up to 2 years(day 1 to 2 years)
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment(day 1 through 90)
- Cause of death as assessed by medical records and autopsy at time of death(variable, survival of the patient)