Prospective Trial of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk (HYPORT-STS)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Time to a major wound complication (MWC)
研究概览
简要总结
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.
详细描述
PRIMARY OBJECTIVES:
I. To determine, in patients with localized, resectable soft tissue sarcoma, whether there is a non-inferior major wound complication rate for patients receiving 42.75 Gy in 15 fractions over 3 weeks compared to historical controls who received 50 Gy in conventional fractionation over 5-6 weeks.
SECONDARY OBJECTIVES:
I. To determine whether local control rates among patients treated with 42.75 Gy in 15 fractions is similar to that observed in previous studies for patients treated with 50 Gy in conventional fractionation over 5-6 weeks.
II. To determine whether patterns of local relapse, relapse free survival, overall survival, or metastatic disease free survival for patients treated with 42.75 Gy in 15 fractions are similar to previously reported studies.
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
- •Tumor located in the soft tissues of the extremities or superficial trunk
- •Deemed a candidate for complete macroscopic resection of the primary sarcoma
- •Histologically confirmed sarcoma arising in soft tissue
- •Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision-->radiation therapy(RT)--> wide excision, as per our standard practice)
- •No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging
- •Has provided written informed consent for participation in this trial
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- •Life expectancy greater than 6 months
- •Patients capable of childbearing are using adequate contraception
- •Available for follow-up
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
- •Women who are pregnant
研究组 & 干预措施
Treatment (hypofractionated RT)
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Treatment (hypofractionated RT)
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Treatment (hypofractionated RT)
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Time to a major wound complication (MWC)
时间窗: Up to 120 days after surgery
A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.
次要结局
- Disease free survival (DFS) time(Up to 10 years after radiation therapy)
- Incidence of late onset toxicity(Up to 120 days after radiation therapy)
- Local recurrence free survival(Up to 10 years after radiation therapy)
- Pattern of local relapse (in radiation field, margin of field, out of radiation field)(Up to 10 years after radiation therapy)
- Time to relapse(Up to 10 years after radiation therapy)
- Disease specific survival time(Up to 10 years after radiation therapy)
- Incidence of acute toxicity other than MWC(Up to 120 days after radiation therapy)
- Functional outcomes(Up to 10 years after radiation therapy)
- Quality of life(Up to 10 years after radiation therapy)