MRIdian "RADAR" Trial - Radiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression Using Stereotactic MRI-guided Adaptive Radiotherapy
概览
- 阶段
- 不适用
- 干预措施
- ViewRay MRIdian Stereotactic Radiosurgery
- 疾病 / 适应症
- Metastatic Epidural Spinal Cord Compression
- 发起方
- University of Miami
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- One-year failure rate
- 状态
- 尚未招募
- 最后更新
- 2个月前
概览
简要总结
The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
研究者
Benjamin Spieler
Assistant Professor of Clinical
University of Miami
入排标准
入选标准
- •Male and female participants ages ≥
- •Solid tumors causing 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.
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
ViewRay MRidian
Participants will receive five (5) doses of radiation therapy over four (4) weeks. The first dose will be given during week 1; after at least 36 hours from the first dose, participants will receive the second dose. The remaining doses will be three (3) doses will be administered once per week during weeks 2, 3, and 4. The treatment plan may change at the discretion of the treating physician. Participants will have three additional doses each week in Weeks 2, 3, and 4.
干预措施: ViewRay MRIdian Stereotactic Radiosurgery
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.
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)