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临床试验/NCT04424732
NCT04424732招募中不适用

Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study

King Hussein Cancer Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Progression free survival (PFS)

研究概览

简要总结

This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.

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
Female
接受健康志愿者

入选标准

  • Women >18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included.
  • Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases.
  • Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT.
  • Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be >5 cm away from each other (defined as Edge to Edge of tumor).

排除标准

  • Non bone metastatic breast cancers
  • Prior history of radiotherapy to same sites of SBRT
  • Pathologic fractures of involved bones
  • Contraindications to radiotherapy including pregnancy and connective tissue disease.
  • Patients with impaired cognitive functions.

结局指标

主要结局

Progression free survival (PFS)

时间窗: 5 years

the interval from diagnosis until disease progression

Overall survival (OS)

时间窗: 5 years

time from diagnosis to death from any cause or last follow-up

次要结局

  • Existing metastasis control(3 years)
  • Appearance of new metastases(3 years)
  • Adverse Events(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulmajeed Dayyat

Consultant Radiation Oncologist

King Hussein Cancer Center

研究点 (2)

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