Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
研究概览
简要总结
This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to 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.
详细描述
PRIMARY OBJCETIVES:
I. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.
SECONDARY OBJECTIVES:
I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.
II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).
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
- •Intermediate or high grade sarcoma
- •Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
- •Recurrent, any grade, no previous radiation therapy
- •Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
- •If a woman is of childbearing potential, a negative serum pregnancy test must be documented
排除标准
- •Active treatment of a separate malignancy
- •History of prior irradiation to the area to be treated
- •Pre-operative chemotherapy (post-op acceptable)
研究组 & 干预措施
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
干预措施: Conventional Surgery (Procedure)
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
时间窗: Up to 2 years
Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.
次要结局
- Local failure(Up to 3 years)
- Overall survival(Up to 3 years)
- Distant metastasis(Up to 3 years)
- Progression free survival(Up to 3 years)
- Regional failure(Up to 3 years)