Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Local Tumor Control Using MRI or CT
研究概览
简要总结
The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for MSKCC participants. Institutional pathologic determination accepted from participating multicenter sites.)
- •Age ≥18 years
- •Life expectancy ≥3 months
- •Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
- •Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and the spinal cord It should be noted that patients with multiple lesions will be eligible as long as there are no overlapping fields of radiation, including at various time frames.
排除标准
- •Primary spine tumor
- •Age < 18
- •Pregnancy
- •Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
- •Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine, 5-fluorouracil) given within one week of radiation treatment
研究组 & 干预措施
single-fraction SRS (24 Gy)
single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
干预措施: single-fraction SRS (Radiation)
single-fraction SRS (24 Gy)
single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
干预措施: Quality of Life Measures (Behavioral)
high-dose hypofractionated SRS (27 Gy in 3 fractions)
hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.
干预措施: high-dose hypofractionated SRS (Radiation)
high-dose hypofractionated SRS (27 Gy in 3 fractions)
hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.
干预措施: Quality of Life Measures (Behavioral)
结局指标
主要结局
Local Tumor Control Using MRI or CT
时间窗: 2 years
will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.
次要结局
- Treatment-related Toxicity Using CTCAE v4.0(2 years)
- Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI(2 years)