Recruiting

Phase 1

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05985148

Conditions

Thoracoabdominal Wall Pain

Secondary to Parietal Pleura or Parietal Peritoneum Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single-fraction stereotactic radiosurgery (SRS)

Study Details

Brief 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.

Conditions

Thoracoabdominal Wall Pain

Secondary to Parietal Pleura or Parietal Peritoneum Disease

Study ID

NCT05985148

Start date

Aug 2, 2023

Status verified date

Jan, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

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.

Primary outcome measure

can be escalated from 70 Gy to 90 Gy without excessive DLTs [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Josh Yamada, MD

212-639-2950 yamadaj@mskcc.org

Amitabh Gulati, MD

212-639-6851

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Josh Yamada, MD

212-639-2950

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Josh Yamada, MD

212-639-2950

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-01-20.