A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
NCT ID: NCT05985148
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2023-08-02
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-fraction stereotactic radiosurgery (SRS)
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.
Single-fraction stereotactic radiosurgery (SRS)
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.
Interventions
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Single-fraction stereotactic radiosurgery (SRS)
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Varian Medical Systems
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Josh Yamada, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Amitabh Gulati, MD
Role: CONTACT
Facility Contacts
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Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Josh Yamada, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-176
Identifier Type: -
Identifier Source: org_study_id
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