NCT02320825
已完成
3 期
Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Spinal Metastases
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Local Tumor Control Using MRI or CT
- 状态
- 已完成
- 最后更新
- 7年前
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.
研究者
入排标准
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
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)
研究点 (4)
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