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Stereotactic Radiosurgery for the Treatment of Chronic Thoracoabdominal Wall Pain
Trial Status: active
This phase I trial tests the side effects, best dose, and feasibility of stereotactic radiosurgery (SRS) in treating patients with chronic thoracoabdominal wall pain (TAWP). Radiation therapy works by damaging DNA, the material inside cells that contains the genetic information about how people develop and function. This DNA damage destroys the cells, and the destruction of cells can help decrease nerve pain. SRS is a type of radiation therapy that delivers targeted high-dose radiation to the brain or spine in less time than standard radiation therapy. SRS can accurately target a very small area of the body, such as a particular nerve that is causing TAWP. Because it is so precise and takes less time, SRS can reduce damage to healthy tissues surrounding the area it targets. SRS is routinely used to treat abnormalities in the brain and spine, such as cancer, epilepsy, trigeminal neuralgia, and arteriovenous malformation. However, SRS is not routinely used to treat chronic TAWP. Using SRS may be a safe and effective treatment option for patients with chronic TAWP.
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 transcutaneous electrical nerve stimulation (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.
Karnofsky Performance Status (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)
Patients with active autoimmune connective tissue disease
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.
* 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, the patient will be ineligible
Abnormal complete blood count. Any of the following:
* Platelet count < 75 K/μL
* Hemoglobin (Hgb) level < 9 g/dl
* White blood cell count (WBC) < 3.5 K/μl
Abnormal coagulation profile: International normalized ratio (INR) > 2.5 INR and/or activated partial thromboplastin time (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 anesthetics
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)
Additional locations may be listed on ClinicalTrials.gov for NCT05985148.
I. To determine maximum tolerated dose (MTD) of single-fraction SRS doses of 70-90 Gy to a small volume encompassing the dorsal root ganglion (DRG) of the involved spinal nerve(s) that can be administered without excessive dose-limiting toxicities (DLTs), specifically Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 toxicity.
SECONDARY OBJECTIVES:
I. Evaluate efficacy outcomes (degree of pain relief and functional improvement achieved using pre-/post-treatment clinical evaluation including change in narcotic requirements, change in Numerical Rating Scale [NRS]/Brief Pain Inventory [BPI]/short-form McGill Pain Questionnaire-2 [SF-MPQ-2] scores, change in incentive spirometry [IS]/peak expiratory flow rate [PEFR]/sit-to-stand testing [STST] functional metrics).
II. Compare the real-time two-dimensional (2D) intra-fractional shifts in target position determined by a gantry mounted kV imager and associated software (Rapidtrack - template matching) with a manual registration determination of the shifts in a retrospective analysis.
III. Compare the real-time three-dimensional (3D) intra-fractional shifts in vertebral position reported by the software (Rapidtrack - Sequential Stereo) with those reported by an independent room-mounted kV imaging system (Exactrac).
IV. Explore the association of dose level and distribution with any grade ≥ 2 observed acute or late toxicity.
V. Explore the correlation between functional outcomes measured using IS/PEFR/STST and degree of pain relief following SRS treatment.
OUTLINE: This is a dose-escalation study.
Patients undergo SRS over 5-10 minutes on study. Patients also undergo myelography and computed tomography (CT) or magnetic resonance imaging (MRI) prior to SRS treatment.
After completion of study treatment, patients are followed up at 1 week, 1, 3 and 6 months, then every 6 months for 2 years.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
