Menu
Recruiting NCT05985148

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

Phase I Interventional Thoracoabdominal Wall Pain Secondary to Parietal Pleura or Parietal Peritoneum Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single-fraction stereotactic radiosurgery (SRS).
Who it may be relevant to
Registry conditions: Thoracoabdominal Wall Pain, Secondary to Parietal Pleura or Parietal Peritoneum Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation 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 measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Identifiers

NCT: NCT05985148 · 22-176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗