NCT06087861招募中2 期
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Post-operative Complication Rate
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
- •Has been offered preoperative radiation and surgery as part of standard-of-care treatment
- •KPS ≥ 70 or ECOG 0 to 2
- •Life expectancy ≥ 6 months
- •If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
- •Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
排除标准
- •History of prior radiation to the area to be treated.
- •Active use of other anti-cancer investigational agents.
- •Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
研究组 & 干预措施
External beam radiotherapy
Experimental
Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
干预措施: External Beam Radiotherapy (Radiation)
结局指标
主要结局
Post-operative Complication Rate
时间窗: 120 days after surgery
Rate of post-operative complications.
次要结局
- Local Recurrence Rate(2 years and 5 years after surgical resection)
研究者
研究点 (1)
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