The Miami "RADAR" Trial - RAdiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- One-year failure rate
研究概览
简要总结
The purpose of this study is to see if treating cancer with radiation therapy administered by the Varian Ethos system can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
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
- •Male and female participants ages ≥
- •Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment.
- •Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria.
- •MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
- •Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI.
- •Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels.
- •Karnofsky performance score ≥60
- •Survival prognosis ≥3 months
- •Medical status allowing surgery.
- •Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression.
- •Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
- •All patients must be ambulatory.
- •Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment).
- •Spine instability neoplastic score <
- •a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.
- •Willing and able to undergo daily MRI during treatment.
- •Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •History and physical within 2 weeks prior to registration.
- •Patients must provide study specific informed consent prior to study entry.
排除标准
- •Unknown primary histology.
- •Patients with rapid neurologic decline.
- •Bony retropulsion causing neurologic abnormality.
- •Non-ambulatory patients.
- •Prior radiation to the involved site.
- •Inability to have an MRI.
- •Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases).
- •Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma).
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
Stereotactic Radiosurgery (SRS) Group
Participants in this group will undergo fractionated stereotactic radiosurgery (SRS) on the Varian Ethos platform, with day of treatment magnetic resonance imaging (MRI) simulation fused to HyperSight commuted tomography (CT) imaging. Participants will receive five (5) doses (fractions) of radiation therapy over four (4) weeks.
Total participation duration is approximately 2 years.
干预措施: Stereotactic Radiosurgery (SRS) (Radiation)
结局指标
主要结局
One-year failure rate
时间窗: Up to 1 year
The one-year failure rate is determined by the number of study participants with clinical failure, defined as needing decompressive surgery at the targeted spinal area due to progression of disease. The rate is determined by the amount of participants with documented clinical failure at any time within ten months of completing protocol therapy. This number is compared to the rate of decompressive surgery in the general population.
Rate of Safe Avoidance of Surgery
时间窗: 6 months
The rate of safe avoidance of surgery will be reported as the number of participants experiencing both (1) the absence of local progression at the treated spine level (s), and (2) the absence of surgery at the treated spine level(s) due to disease progression and/or structural instability, after completion of protocol therapy.
次要结局
- Local progression (LP) rate(Up to 10 weeks)
- Rate of radiation myelopathy(Up to 6 months)
- In-field progression (IFP) rate(Up to 1 year)
- Distant progression (DP) rate(Up to 1 year)
- Failure-Free Survival (FFS)(Up to 2 years)
- Mean planned target volume (PTV) Dose Mean (DMean)(Up to 1 year)
- Area under the curve (AUC) for receiving operating characteristic analysis(Up to 1 year)
- Rate of vertebral compression fracture(Up to 2 years)
- Number of Treatment Related Adverse Events as Measured By CTCAE v.5(Up to 1 year)
- Local Pain Control as Measured by Brief Pain Inventory (BPI)(Up to 2 years)
- Local control (LC) rate(Up to 10 weeks)
- Change in mean relative thecal sac patency(Baseline, Up to 10 weeks)
- Quality of Life Assessed Using FACT-G(Up 2 years)
- Maximum planned target volume (PTV) maximum dose (Dmax)(Up to 1 year)
- PTV D80(Up to 1 year)
- Change in mean relative in epidural tumor(Baseline, Up to 10 weeks)
- Overall epidural tumor response rate(Up to 10 weeks)
- Change in thecal sac decompression rate(Baseline, Up to 14 weeks)
- Quality of Life Assessed Using EuroQol (EQ) Five Dimension (5D) Five Level (5L) (EQ-5D-5L)(Up to 2 years)
- Spinal cord Dmax(Up to 1 year)
- Spinal cord D0.03(Up to 1 year)
- Overall Survival (OS)(Up to 2 years)
- Rate of ambulation preservation(Up to 2 years)
- PTV D95(Up to 1 year)
- Spinal cord D0.1(Up to 1 year)
- Spinal cord D1(Up to 1 year)
- Spinal cord D50(Up to 1 year)
- Dice's coefficient(Up to 1 year)
- Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow(Day 1 of Treatment, Up to 4 weeks)
- Rate of Radiation Myelopathy (RM)(Baseline, Up to 8 months)
- Rate of Vertebral Compression Fracture (VCF)(Up to 2 years)
- Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events(Up to 12 months)
- Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0(Baseline, Up to 6 months)
- Rate of Ambulation Preservation(Up to 2 years)
研究者
Benjamin Spieler
Assistant Professor of Clinical
University of Miami