Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathologic Necrosis Score on Surgical Pathology Report
研究概览
简要总结
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
详细描述
Standard treatment for soft tissue sarcomas is a combination of radiation therapy and surgery. Radiation therapy is usually done prior to the surgical removal of the tumor. Most commonly, conventionally fractionated radiotherapy is used for soft tissue sarcomas, in which radiation therapy is given over 25 treatments in a time period of approximately 5 weeks.
Conventionally fractionated radiotherapy is radiation treatment that is delivered over the course of several days; typically divided into doses that are delivered each weekday over a set number of weeks. Each radiation treatment is called a "dose fraction", thus the name "fractionated".
Hypofractionated radiotherapy is a technique in which a higher dose of radiation is given over a fewer number of treatments. Early studies have suggested that hypofractionated radiotherapy will be safe and effective for pre-operative treatment of soft tissue sarcomas. However, because this disease is rare, there are different kinds of soft tissue sarcomas, these tumors can occur anywhere in the body, and conventionally fractionated radiotherapy remains standard, more study is needed to find out if hypofractionated radiotherapy is a safe and effective treatment for this disease.
Therefore, the investigators plan to compare patients treated with conventionally fractionated radiotherapy over 25 treatments in a time period of 5 weeks to patients treated with hypofractionated radiotherapy over 5 treatments in a time period of 1-2 weeks.
The investigators hypothesize hypofractionated radiotherapy in the pre-operative treatment of soft tissue sarcomas can effectively treat soft tissue sarcomas while minimizing side effects and minimizing the time between diagnosis and surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
- •No prior sarcoma-directed chemotherapy or radiotherapy
- •Age ≥ 18 years
- •Karnofsky performance status ≥ 60
- •Able to understand and sign an informed consent
- •Life expectancy of greater than 12 weeks
- •Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion
- •Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)
- •Adequate bone marrow function as defined by absolute neutrophil count > 500/mcL, hemoglobin > 8 g/dL, platelets > 50,000/mcL; adequate renal function as defined by creatinine clearance > 30 mL/min
排除标准
- •Unable to undergo imaging or positioning necessary for radiotherapy planning
研究组 & 干预措施
Conventional Fractionated
radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
干预措施: Conventional Fractionated (Radiation)
Hypofractionated
the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
干预措施: Hypofractionated (Radiation)
结局指标
主要结局
Pathologic Necrosis Score on Surgical Pathology Report
时间窗: up to 12 weeks from randomization
scores range from 0 to 2, lower scores mean there was less dying tissue present
次要结局
- Incidence of Surgical Margin Status R0, R1, and R2(up to 12 weeks from randomization)
- Incidence of acute wound healing complications up to 120 days after surgery(up to 6 months from randomization (up to 120 days after surgery))
- Incidence of secondary operation for wound repair(up to 6 months from randomization (up to 120 days after surgery))
- Incidence of Late Toxicity(up to 2 years plus or minus 3 months)
- Progression Free Survival (PFS)(up to 5 years)
- Rate of Local Tumor Recurrence(up to 5 years)