已扩散至骨骼的癌症患者的立体定向放射治疗 (SBRT) 和手术稳定的研究
评估术前立体定向放疗治疗需要手术稳定的骨转移性疾病的安全性和有效性的初步研究
The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
New Jersey
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Basking Ridge、New Jersey、美国、07920
- Memorial Sloan Kettering Basking Ridge
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Middletown、New Jersey、美国、07748
- Memorial Sloan Kettering Monmouth
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Montvale、New Jersey、美国、07645
- Memorial Sloan Kettering Bergen
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New York
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Commack、New York、美国、11725
- Memorial Sloan Kettering Cancer Commack
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Harrison、New York、美国、10604
- Memorial Sloan Kettering Westchester
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center (All protocol activities)
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Uniondale、New York、美国、11553
- Memorial Sloan Kettering Nassau
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases
- Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis
- Age at enrollment ≥18 years
- Life expectancy >3 months
- Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site
- Surgical candidate, as determined by the treatment team
- Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity.
- Must agree to practice an effective contraceptive method (for those with reproductive potential)
Exclusion Criteria:
- Prior radiotherapy to the treatment site
- Prior surgery involving the treatment site
- Tumor volume or distribution precluding effective SBRT
- Expected skin dose at the operative site ≥9 Gy
- Imminently impending fracture requiring immediate stabilization surgery
- Involvement of proximal tibia
- Autoimmune connective tissue disorder
- Administration of radiosensitizing medication 3 days before, during, and 3 days after RT
- Active infection
- Absolute neutrophil count <1.0
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Preoperative Stereotactic Body Radiotherapy (SBRT)
Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed. |
Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
risk of major wound complications
大体时间：6 weeks after preoperative SBRT
|
Major wound complications are defined as reoperation for wound revision, clinically diagnosed surgical site infection, readmission for wound care, or prolonged (>3 weeks postoperatively) active wound care. |
6 weeks after preoperative SBRT
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
rate of local control
大体时间：1 year
|
Failure of local control is defined as a new lesion within the radiation or surgical field, significant progression of an existing lesion, or reoperation or reirradiation due to tumor progression. |
1 year
|
合作者和调查者
调查人员
- 首席研究员：Maksim Vaynrub, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 21-216
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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