NCT07478289招募中2 期
OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines
研究概览
简要总结
Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases.
This study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.
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
- •Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
- •Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT
- •Post-operative SBRT is permitted (after stabilization and/or decompression surgery) as long as no prior radiotherapy had been delivered to the spinal level planned for trial treatment and paraspinal disease is present
- •ECOG performance status 0-2
- •Able to tolerate protocol SBRT
- •Age 18 years or older
- •Patient is able and willing to complete the Patient Diary (pain and analgesic use)
- •Consent must be appropriately obtained in accordance with local requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
- •Patients must be accessible for treatment and follow-up
- •Treatment to begin within 14 days (ideally 7 days) of radiotherapy simulation
排除标准
- •Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)
- •Prior radiotherapy in the spine target of interest
- •Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of > 12
- •Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurologic deficit in the form of motor, bowel or bladder dysfunction
- •Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely
- •Cytotoxic chemotherapy within 1 week prior to radiotherapy delivery
研究组 & 干预措施
Radiation Boost
Experimental
Participants would receive a radiation boost to their spinal metastases (as described in "Intervention")
干预措施: Radiation Boost (Radiation)
结局指标
主要结局
Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines
时间窗: Up to 12 months after completion of radiation therapy
次要结局
- Treatment-related side effects as assessed by CTCAE v5.0(Up to 12 months following completion of radiation therapy)
- Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS)(Up to 12 months following completion of radiation therapy)
- Pain at treated spinal metastases, per ICPRE (International Consensus on Palliative Radiotherapy Endpoints)(3 and 6 months following completion of radiation therapy)
- Type of progression(Up to 12 months after completion of radiation therapy)
研究者
研究点 (1)
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