Using stereotactic radiosurgery to relieve chest and stomach wall pain
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
This study is testing if a special type of targeted radiation therapy can help people with ongoing chest and stomach wall pain caused by nerve problems when other treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05985148 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of stereotactic radiosurgery (SRS) as a treatment for chronic thoracoabdominal wall pain (TAWP) caused by specific spinal nerve issues. Researchers will evaluate different doses of SRS to determine the highest dose that results in minimal side effects. Patients with a history of TAWP that has not responded adequately to conventional pain management will be enrolled. The study aims to provide a new therapeutic option for individuals suffering from this debilitating condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic thoracoabdominal wall pain that has not been adequately managed by conventional therapies.
Not a fit: Patients with a life expectancy of less than six months or those with bilateral thoracoabdominal wall pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic pain for patients suffering from thoracoabdominal wall pain.
How similar studies have performed: Other studies utilizing stereotactic radiosurgery for pain management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Josh Yamada, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Josh Yamada, MD
- Email: yamadaj@mskcc.org
- Phone: 212-639-2950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.