A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thoracoabdominal Wall Pain, Secondary to Parietal Pleura or Parietal Peritoneum Disease

Intervention / Treatment
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* Radiation: Single-fraction stereotactic radiosurgery (SRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a phase I clinical trial investigating the use of frameless single-fraction stereotactic radiosurgery (SRS) to treat chronic unilateral thoracoabdominal wall pain limited in distribution to three or fewer spinal levels from T3-T11 through ablation of the dorsal spinal nerve root.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-fraction stereotactic radiosurgery (SRS)<br>Patients will be treated with single-fraction radiation therapy at three dose levels: 70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques. | Radiation: Single-fraction stereotactic radiosurgery (SRS)<br>* Patients will be treated with single-fraction radiation therapy at three dose levels: 70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| can be escalated from 70 Gy to 90 Gy without excessive DLTs | 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic Radiosurgery (SRS), Ablation of the Dorsal Spinal Nerve, 22-176