NCT05985148招募中1 期
A Phase I Dose Escalation Trial for Treatment of Chronic Thoracoabdominal Wall Pain Through Ablation of the Dorsal Spinal Nerve Using Single-Fraction Stereotactic Radiosurgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- can be escalated from 70 Gy to 90 Gy without excessive DLTs
研究概览
简要总结
The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will test different doses of SRS to find the highest dose that causes few or mild side effects.
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
- •Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic paravertebral nerve block or TENS (if results of the paravertebral nerve block are inconclusive) performed by an attending anesthesiologist specializing in pain management prior to study enrollment.
- •Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with conventional pharmacologic therapy for analgesia) as determined by an attending physician specializing in pain management.
- •KPS ≥ 60%
- •Age ≥ 18 years old
排除标准
- •Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
- •Patients with active autoimmune connective tissue disease
- •Patients with bilateral TAWP
- •Patients with preexisting pneumothorax
- •Patients with preexisting excessive pleural effusion (extending > 3 vertebral levels)
- •Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
- •Unable to undergo a diagnostic paravertebral nerve block
- •Unable to undergo at least one of either a myelogram or spine MRI
- •Patients for whom external beam treatment plans to deliver the prescription SRS dose to the lesion of interest cannot be safely designed as specified by the Dose Constraint Guidelines in Appendix 2
- •Evaluation of any radiation doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum) will be taken into consideration
- •If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
- •Abnormal complete blood count. Any of the following:
- •Platelet count < 75 K/µL
- •Hgb level < 9 g/dl
- •WBC < 3.5 K/µl
- •Abnormal coagulation profile: INR > 2.5 INR and/or APTT > 80 seconds. Patients who are on anticoagulation medication that may not be safely held for the myelogram procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
- •Allergy to local anesthestics
- •Local infection at the site of injection of anesthetic
- •Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
- •Severe respiratory disease (i.e. oxygen dependent)
结局指标
主要结局
can be escalated from 70 Gy to 90 Gy without excessive DLTs
时间窗: 2 years
DLT's CTCAE grade ≥ 3 toxicity. Acute and late toxicity will be assessed by investigators and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Toxicities that cannot be graded using the Common Toxicity Criteria will be graded as 1 (mildly symptomatic), 2 (moderately symptomatic but not interfering significantly with function), 3 (causing significant interference with function), or 4 (life-threatening).
次要结局
未报告次要终点
研究者
研究点 (13)
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