RECRUITING

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

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Conditions

Thoracoabdominal Wall PainSecondary to Parietal Pleura or Parietal Peritoneum DiseaseStereotactic Radiosurgery (SRS)Ablation of the Dorsal Spinal Nerve22-176

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-08-02
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05985148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * KPS ≥ 60%
  4. * Age ≥ 18 years old
  1. * Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
  2. * Patients with active autoimmune connective tissue disease
  3. * Patients with bilateral TAWP
  4. * Patients with preexisting pneumothorax
  5. * Patients with preexisting excessive pleural effusion (extending \> 3 vertebral levels)
  6. * Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
  7. * Unable to undergo a diagnostic paravertebral nerve block
  8. * Unable to undergo at least one of either a myelogram or spine MRI
  9. * 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
  10. * 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
  11. * If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
  12. * Abnormal complete blood count. Any of the following:
  13. * Platelet count \< 75 K/µL
  14. * Hgb level \< 9 g/dl
  15. * WBC \< 3.5 K/µl
  16. * 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.
  17. * Allergy to local anesthestics
  18. * Local infection at the site of injection of anesthetic
  19. * Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
  20. * Severe respiratory disease (i.e. oxygen dependent)

Contacts and Locations

Study Contact

Josh Yamada, MD
CONTACT
212-639-2950
yamadaj@mskcc.org
Amitabh Gulati, MD
CONTACT
212-639-6851

Principal Investigator

Josh Yamada, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Josh Yamada, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-02
Study Completion Date2028-08

Study Record Updates

Study Start Date2023-08-02
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Stereotactic Radiosurgery (SRS)
  • Ablation of the Dorsal Spinal Nerve
  • 22-176

Additional Relevant MeSH Terms

  • Thoracoabdominal Wall Pain
  • Secondary to Parietal Pleura or Parietal Peritoneum Disease