Safety, Efficacy, and Mechanism of Pre-operative Spatially Fractionated GRID Radiation Therapy in Patients With Extremity Soft Tissue Sarcoma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Grade 2 or higher post-operative wound complications after GRID-3 months
研究概览
简要总结
Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications.
GRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.
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
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Inclusion Criteria:
- •Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- •Age ≥ 18 years at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).
- •Histological or cytological evidence/confirmation of extremity soft tissue sarcoma as determined by core-needle biopsy or excision biopsy. If the diagnostic tissue is not available or sufficient to perform correlative studies, must be willing to provide the mandatory pre-treatment core-needle biopsy. In some cases of extremity STS, subjects undergo an attempted surgical resection for a presumed benign condition and the specimen reveals malignancy. Such subjects are allowed so long as a complete, oncologic, resection was not performed/attempted and there is ≥ 5 cm of the remaining primary tumor.
排除标准
- •Subjects meeting any of the exclusion criteria listed below at baseline will be excluded from the study.
- •Subjects who have received prior radiotherapy to the tumor site.
- •Subjects who have undergone complete tumor resection of the primary tumor or who have developed tumor recurrence after resection.
- •History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb within the last 5 years.
- •History of clinically significant lymphedema in the treated limb.
- •History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (any type), or other collagen vascular disease that may pose a relative contraindication, due to increased risk of skin or soft tissue toxicity, with radiation.
研究组 & 干预措施
Fractionated grid radiation therapy
Subjects with resectable extremity soft tissue sarcoma received neoadjuvant grid radiation therapy (GRID), followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.
干预措施: GRID therapy (Radiation)
结局指标
主要结局
Grade 2 or higher post-operative wound complications after GRID-3 months
时间窗: 3 months
Safety will be quantified as the incidence of Grade 2 or higher post-operative wound complications after GRID, the standard of care XRT, and surgery. Wound complications will be graded according to The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. CTCAE is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
次要结局
- The tumor specimen of the surgery(At the time of surgery (Approximately 17th week))
- Grade 2 or higher post-operative wound complications after GRID-6 months(3 months to 6 months)
- The comparative effect of GRID(At the time of surgery (Approximately 17th week after completion of radiotherapy))
- Long Term Safety(6 months after completrion of radiotherapy)