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

RecruitingPhase 1NCT05985148
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
  • Thoracoabdominal Wall Pain
  • Secondary to Parietal Pleura or Parietal Peritoneum Disease
Interventions
  • Radiation: Single-fraction stereotactic radiosurgery (SRS)
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems
Start date
2023-08-02
Primary completion
2028-08
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
7

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05985148