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

Last updated: January 15, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Single-fraction stereotactic radiosurgery (SRS)

Clinical Study ID

NCT05985148
22-176
  • Ages > 18
  • All Genders

Study Summary

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.

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

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Single-fraction stereotactic radiosurgery (SRS)
Phase: 1
Study Start date:
August 02, 2023
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.