Pilot Study Evaluating Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Local Disease Control Assessed by Physical Examination
研究概览
简要总结
This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).
详细描述
BACKGROUND OVERVIEW: Hypofractionation has several potential advantages over conventional radiation. First, the biological equivalent dose to the tumor is higher with hypofractionation than it is with conventional radiation. In between radiation treatments there is repair of the radiation damaged cancer cells (on a cell survival curve this region of repair is referred to as the "shoulder" of the curve). Some cell lines are better at repair than others. Sarcoma is often referred to as a "radioresistant" tumor, which means that sarcoma cell lines have a larger capacity for radiation repair than do other cell lines. A treatment that can deliver a high dose in fewer fractions can potentially overcome some of this repair. There is a concept in radiation known as "biologically equivalent dose" (BED) which states that a higher dose per fraction results in more tumor kill than a lower dose per fraction. For example, radiation delivered to a total of 60 Gy in three 20 Gy fractions is the equivalent of 150 Gy in 2 Gy fractions.
BACKGROUND RATIONALE: It is important to conduct this study because hypofractionation not only decreases treatment package time and cost of care, but it also potentially improves patient convenience and quality of life and could impact radiologic and pathologic variables in a positive way by leading to more tumor cell kill. This could potentially change the paradigm of the current management of STS of the extremity and chest-wall.
HYPOTHESIS
Preoperative hypofractionated radiation therapy for localized soft tissue sarcomas (STS) will result in local control and toxicity similar to conventional fractionation with less cost, more patient convenience and decreased overall treatment time.
TREATMENT: Image-guided radiation therapy is mandatory. PREOPERATIVE: (1) Either 3D conformal radiotherapy or intensity modulated radiation therapy (IMRT). (2) A prescription dose of 35 Gy in 5 fractions given every other day with at least 48 hours in between each fraction will be prescribed to cover 95% of the planning target volume. TREATMENT SCHEDULE: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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
- •≥ 18 years of age
- •Core needle biopsy obtained
- •Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
- •Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
- •Medically operable
- •No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
- •MRI obtained of the affected extremity or chest-wall
- •CT chest acquired to assess distant disease
- •Karnofsky Performance Status (KPS) 60 or above
- •Informed consent obtained prior to study entry
排除标准
- •Patients who have metastatic disease
- •Pregnant women
- •Women of childbearing potential and male participants must practice adequate contraception.
- •Disease pathology other than sarcoma subtypes
- •Patients with a history of metastatic disease from a primary other than sarcoma
- •Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
- •STS of non-extremity or chest-wall regions
- •Tumor size ≥ 20 cm maximal dimension
结局指标
主要结局
Local Disease Control Assessed by Physical Examination
时间窗: 2 Years
This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)
时间窗: 2 years
This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
次要结局
- Musculoskeletal Tumor Rating Scale (MSTS) Score(Baseline, prior to surgery and 24 months after surgery)
- Disease-free Survival(2 Years)
- Overall Survival(2 Years)
- Radiologic Changes Due to Hypofractionated Radiation.(4 weeks after radiation therapy)
- Pathologic Changes Due to Hypofractionated Radiation.(2 weeks after surgery)
- Treatment-related Necrosis and Fibrosis(2 years)
研究者
Ciani M Ellison, MD
Assistant Professor
Medical College of Wisconsin