Thoracoabdominal Wall PainPhase 1NCT05985148
A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
A Phase 1 study testing Single-fraction stereotactic radiosurgery (SRS) in people with Thoracoabdominal Wall Pain and Secondary to Parietal Pleura or Parietal Peritoneum Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Wall Pain, Secondary to Parietal Pleura or Parietal Peritoneum Disease
- What is being tested?
- Single-fraction stereotactic radiosurgery (SRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Aug 2023to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amitabh Gulati, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Josh Yamada, MD, 212-639-2950
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Josh Yamada, MD, 212-639-2950
About this study
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
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.
- Being tested
- Single-fraction stereotactic radiosurgery (SRS)
- Keywords
- Stereotactic Radiosurgery (SRS), Ablation of the Dorsal Spinal Nerve, 22-176
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Single-fraction stereotactic radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Aug 2023
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Wall PainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Josh Yamada, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985148
- Sponsor's protocol ID
- 22-176
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05985148
- Acronym / sponsor ID
- 22-176
- Keywords
- Stereotactic Radiosurgery (SRS), Ablation of the Dorsal Spinal Nerve, 22-176
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-fraction stereotactic radiosurgery (SRS) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Single-fraction stereotactic radiosurgery (SRS) |
Primary outcome
can be escalated from 70 Gy to 90 Gy without excessive DLTs
Time frame: 2 years
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amitabh Gulati, MD contact
Josh Yamada, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single-fraction stereotactic radiosurgery (SRS) in people with Thoracoabdominal Wall Pain and Secondary to Parietal Pleura or Parietal Peritoneum Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josh Yamada, MD (212-639-2950, yamadaj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can be escalated from 70 Gy to 90 Gy without excessive DLTs (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.