Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy
研究概览
简要总结
Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues.
详细描述
The study focuses on the following primary Objectives:
-
To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
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Prospectively establish a baseline estimate of local control for patients with MST (Ewing's sarcoma family of tumors (ESFT), rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (STS)) treated with image guided radiation therapy.
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Demonstrate that the increased level of conformality afforded by image guided radiation therapy does not reduce its efficacy relative to previously utilized non-image guided radiation therapy techniques in patients with Ewing's sarcoma family of tumors, resected soft tissue sarcomas, and group III rhabdomyosarcomas.
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Assess local and regional patterns of failure for patients with MST treated with image guided radiation therapy relative to their targeted volumes.
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Provide a long term (>5 year) estimate of local disease control for patients with MST (Ewing's sarcoma family of tumors (ESFT)), rhabdomyosarcoma (RMS), and non-rhabdomyosarcoma soft tissue sarcoma (STS) treated with image guided radiation therapy.
The study focuses on the following secondary objectives:
- Establish a quantitative baseline estimate of radiation dose-related changes in normal tissues using novel objective measures of somatic change, musculoskeletal function, tissue biochemistry and physiology.
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
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than or equal to 25 years (new enrollments only). No age limit on participants who reconsent or reenroll.
- •Musculoskeletal tumor involving the primary site of origin requiring definitive, pre-operative or post-operative irradiation to that primary site.
- •No prior therapeutic irradiation at the primary site except for emergent radiation to the primary site lasting 1 week or less (5 treatment days) that can be dosimetrically accounted for in the analysis.
- •Negative serum or urine beta-HCG for females of child bearing age.
- •Patients will be stratified into 2 groups for evaluation of secondary objective endpoints based on the absence or presence of metastatic disease.
- •Patients may enter this study in specific clinical situations often defined by multimodality protocols that include the use of radiation therapy, including irradiation alone or combined with surgery (following surgical resection that may be macroscopically complete or incomplete, with positive or negative histologic margins) and/or chemotherapy (following neoadjuvant chemotherapy or combined with post-irradiation adjuvant chemotherapy).Patients requiring regional nodal irradiation and/or metastatic site irradiation are allowed as long as the primary site requires radiation.Patients with recurrent tumors or second malignant neoplasms are allowed on this study if the current primary tumor site requiring irradiation has not previously been irradiated. The treatment plan detailed in this study will allow most patients to be concurrently enrolled on institutional and COG studies.
- •Patients enrolled prior to amendment 4.0, who are still in active participation will be reconsented to the current version of the protocol (5.0).
排除标准
- 未提供
研究组 & 干预措施
Treatment
Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations.
干预措施: image-guided radiotherapy (Radiation)
结局指标
主要结局
Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy
时间窗: 5-years follow-up after completion of therapy.
The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
Cumulative Incidence of Local Failures at 10 Years in Patients With Image Guided Radiation Therapy
时间窗: 10- years follow-up after completion of therapy
The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
次要结局
- Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities.(Time to local failure (local control) over 10 years follow-up after completion of therapy)
- Muscle Function Over Time, PET, DCE-MR, T2* MR Quantitative Parameters.(Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy.)
- Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities.(Time to local failure (local control) over 5 years follow-up after completion of therapy)