Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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
Abnormal complete blood count. Any of the following:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josh Yamada, MD | Contact | 212-639-2950 | yamadaj@mskcc.org | |
| Amitabh Gulati, MD | Contact | 212-639-6851 |
| Name | Affiliation | Role |
|---|---|---|
| Josh Yamada, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
|