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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Thoracoabdominal Wall Pain; Secondary to Parietal Pleura or Parietal Peritoneum Disease

Treatments: Radiation: Single-fraction stereotactic radiosurgery (SRS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05985148

22-176

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Single-fraction stereotactic radiosurgery (SRS)

Experimental group

Description:

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.

Treatment:

Radiation: Single-fraction stereotactic radiosurgery (SRS)