A Phase II Clinical Trial Evaluating the Efficacy of Combining Thermal Ablation and Spine Stereotactic Radiosurgery for Patients With Spine Metastases With Moderate to Severe Epidural Involvement
概览
- 阶段
- 2 期
- 干预措施
- Computed Tomography
- 疾病 / 适应症
- 未指定
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Local tumor control rate
- 状态
- 进行中（未招募）
- 最后更新
- 15天前
概览
简要总结
This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.
详细描述
PRIMARY OBJECTIVE: I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement. SECONDARY OBJECTIVES: I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months. II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months. IIa. Calculate decrease in epidural tumor volume (by volumetric measurements). IIb. Calculate increase in thecal sac patency (by volumetric measurements and according to Bilsky method). III. To determine overall survival at 6, 12, 18, and 24 months. IV. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines. V. To assess the effect of treatment on quality of life (QOL), measured at 1 month and every 3 months after with validated outcome measure tools. VI. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life. OUTLINE: Patients undergo thermal ablation and computed tomography (CT)-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion. After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months.
研究者
入排标准
入选标准
- •At least 18 years of age.
- •Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see
排除标准
- •), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
- •Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
- •The vertebral body site to be treated must be located from T2-T
- •No more than 3 contiguous or discontiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
- •Motor strength \>/=4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
- •ECOG performance status \</=2 or Karnofsky performance status (KPS) \>/=50
- •Life expectancy \>3 months.
- •Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
研究组 & 干预措施
Treatment (thermal ablation, SSRS)
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
干预措施: Computed Tomography
Treatment (thermal ablation, SSRS)
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
干预措施: Quality-of-Life Assessment
Treatment (thermal ablation, SSRS)
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
干预措施: Questionnaire Administration
Treatment (thermal ablation, SSRS)
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
干预措施: Stereotactic Radiosurgery
Treatment (thermal ablation, SSRS)
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
干预措施: Thermal Ablation Therapy
结局指标
主要结局
Local tumor control rate
时间窗: At 6 months
Kaplan-Meier estimates will be used.
次要结局
- Epidural control assessed by volumetric measurements(Up to 24 months)
- Overall survival(Up to 24 months)
- Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form(Baseline to 24 months)
- Local tumor control(Up to 24 months)
- Changes in symptoms assessed by physical examination(Baseline to 24 months)
- Changes in symptoms assessed by neurological examination(Baseline to 24 months)
- Changes in quality of life (QOL) assessed by the MD Anderson Symptom Inventory Spine Tumor form(Baseline to 24 months)
- Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)(Baseline to 24 months)