A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Major Wound Complications
研究概览
简要总结
This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.
详细描述
PRIMARY OBJECTIVE:
I. To report the major acute wound complication rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.
SECONDARY OBJECTIVES:
I. To report the 5-year local failure rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.
II. To report the 5-year disease-free survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.
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
- •Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either -
- •Deemed a candidate for complete macroscopic resection of the primary sarcoma OR
- •Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy
- •No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3
- •Life expectancy greater than 6 months
- •Patients capable of childbearing must use adequate contraception
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Ability to provide written informed consent
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
排除标准
- •Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues
- •Patients with nodal or distant metastases
- •Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
研究组 & 干预措施
Treatment (hypofractionated radiation therapy, resection)
Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.
干预措施: Resection (Procedure)
Treatment (hypofractionated radiation therapy, resection)
Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Treatment (hypofractionated radiation therapy, resection)
Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.
干预措施: Quality-of-Life Assessment (Other)
Treatment (hypofractionated radiation therapy, resection)
Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Major Wound Complications
时间窗: Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care such as intravenous antibiotics or persistent deep packing for 120 days or longer).
次要结局
- Local Failure Rate(Up to 1 year)
- Incidence of Late Adverse Events(Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy)
- Pattern of Relapse(Up to 1 years)
- Incidence of Adverse Events(Up to 1 year)
- Change in Quality of Life - PROMIS-10(Baseline up to 24 months post-surgery)
- Change in Quality of Life - TESS(Baseline up to 24 months post-surgery)
- Percent Probability of Disease-free Survival at 1 Year(up to 1 year)
- Percent Probability of Overall Survival at 1 Year(Up to 1 year)