Phase
Condition
N/ATreatment
Single-fraction stereotactic radiosurgery (SRS)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have a documented history of chronic (≥ 3 months) thoracoabdominalwall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed bydiagnostic paravertebral nerve block or TENS (if results of the paravertebral nerveblock are inconclusive) performed by an attending anesthesiologist specializing inpain management prior to study enrollment.
Patients must have TAWP that is inadequately relieved by a trial of conventionalpharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment withconventional pharmacologic therapy for analgesia) as determined by an attendingphysician specializing in pain management.
KPS ≥ 60%
Age ≥ 18 years old
Exclusion
Exclusion Criteria:
Patients with a life expectancy of < 6 months as predicted by the Adult ComorbidityIndex (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 vertebrallevels)
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 doseto the lesion of interest cannot be safely designed as specified by the DoseConstraint Guidelines in Appendix 2
Evaluation of any radiation doses previously delivered to spinal cord/caudaequina 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 notedin 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 whoare on anticoagulation medication that may not be safely held for the myelogramprocedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours forlow-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)
Study Design
Connect with a study center
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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