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

NCT05985148 | Recruiting Phase 1

• 1 other identifier: 22-176
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• can be escalated from 70 Gy to 90 Gy without excessive DLTs

  DLT's CTCAE grade ≥ 3 toxicity. Acute and late toxicity will be assessed by investigators and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Toxicities that cannot be graded using the Common Toxicity Criteria will be graded as 1 (mildly symptomatic), 2 (moderately symptomatic but not interfering significantly with function), 3 (causing significant interference with function), or 4 (life-threatening).

  2 years

Study Arms (1)

Single-fraction stereotactic radiosurgery (SRS)

EXPERIMENTAL

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.

Radiation: Single-fraction stereotactic radiosurgery (SRS)

Interventions

Single-fraction stereotactic radiosurgery (SRS) RADIATION

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Josh Yamada, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josh Yamada, MD

CONTACT

212-639-2950; yamadaj@mskcc.org

Amitabh Gulati, MD

CONTACT

212-639-6851

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase I clinical trial investigating the use of frameless single-fraction stereotactic radiosurgery (SRS) to treat chronic unilateral thoracoabdominal wall pain limited in distribution to three or fewer spinal levels from T3-T11 through ablation of the dorsal spinal nerve root.

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: August 2, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (7)