Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Local control rate
研究概览
简要总结
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
详细描述
Study Objectives:
Primary:
- To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
- Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.
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
- •Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
- •ECOG performance status 0-2
- •Patient must be deemed able to comply with radiation treatment and surgery
排除标准
- •History of prior radiation to the same area to be irradiated
- •Pregnancy
- •Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
结局指标
主要结局
Local control rate
时间窗: Approximately 2 years
Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.
次要结局
- Complication rate(Approximately 2 years)
研究者
Eric Shinohara
Principal Investigator
Vanderbilt-Ingram Cancer Center