Clinical trial NCT05985148: A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Thoracoabdominal Wall Pain
Secondary to Parietal Pleura or Parietal Peritoneum Disease
Keywords: Stereotactic Radiosurgery (SRS)
Ablation of the Dorsal Spinal Nerve
22-176
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2023-08-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: can be escalated from 70 Gy to 90 Gy without excessive DLTs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Josh Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References: