SRS for Thoracoabdominal Wall Pain

Recruiting at 6 trial locations

Overseen By Amitabh Gulati, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: Autoimmune disease, Pneumothorax, Severe respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stereotactic radiosurgery (SRS), a precise and focused form of radiation therapy, is safe and effective for treating chronic thoracoabdominal wall pain (TAWP). Researchers test different doses of SRS to determine the maximum amount that causes only mild side effects. The trial may suit those who have experienced TAWP for at least three months without relief from regular pain medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medication (blood thinners), you may need to stop them for a certain period before some procedures.

What prior data suggests that stereotactic radiosurgery (SRS) is safe for treating thoracoabdominal wall pain?

Research has shown that stereotactic radiosurgery (SRS) is usually well-tolerated. In past studies, SRS treated patients with various conditions and resulted in minimal side effects. For instance, when used on patients with brain tumors caused by cancer spreading, the side effects were manageable.

Another study found that single-session treatments like SRS can be more comfortable for patients, as they reduce the number of hospital visits. This reduction lowers the risk of complications from frequent hospital trips.

In this trial, researchers are testing different doses of SRS to ensure safety, focusing on finding the highest dose that causes only mild or few side effects. While SRS is generally safe, the trial aims to enhance its safety further. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for thoracoabdominal wall pain, which often includes medications like opioids or physical therapies, single-fraction stereotactic radiosurgery (SRS) offers a non-invasive alternative. This treatment is unique because it delivers a high dose of radiation in just one session, precisely targeting the affected area using image-guided techniques. Researchers are excited about SRS because it has the potential to provide significant pain relief quickly, with fewer sessions and potentially fewer side effects compared to prolonged medication use.

What evidence suggests that SRS is effective for thoracoabdominal wall pain?

Research has shown that stereotactic radiosurgery (SRS) effectively reduces pain for patients with cancer that has spread to the spine, achieving an 85% improvement rate in pain relief. This treatment uses focused radiation to target specific areas, reducing the number of hospital visits and increasing patient comfort. In this trial, participants will receive single-fraction SRS at different dose levels to study its potential for relieving pain in the chest and abdominal wall. Additionally, SRS is often considered more cost-effective than other radiation treatments. Although limited data exists on its use for chest and abdominal wall pain, its success in treating other types of pain suggests promising potential. ^{2 3 4 6 7}

Who Is on the Research Team?

Josh Yamada, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic pain in the chest or stomach wall, lasting at least 3 months and not relieved by standard pain medication. They must have a certain level of physical functioning (KPS ≥ 60%) and life expectancy over 6 months. Exclusions include severe spinal deformities, excessive pleural effusion, inability to undergo specific diagnostic procedures, abnormal blood counts or coagulation profiles, severe respiratory disease, active autoimmune diseases, pneumothorax, recent chemotherapy or allergies to local anesthetics.

Inclusion Criteria

I have had chest or belly wall pain for 3 months, confirmed by a specific nerve block test.

My severe pain is not relieved by standard pain medication.

I can care for myself but may need occasional help.

Exclusion Criteria

Patients with bilateral TAWP

Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27)

I have a large amount of fluid in my chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-fraction stereotactic radiosurgery (SRS) at escalating doses of 70 Gy, 80 Gy, and 90 Gy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with acute and late toxicity assessed

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Single-fraction stereotactic radiosurgery (SRS)

Trial Overview The study tests stereotactic radiosurgery (SRS) as a treatment for chronic thoracoabdominal wall pain (TAWP). Different doses of SRS will be used to determine the highest dose that's safe with few mild side effects. The effectiveness and practicality of SRS for this type of pain are also being evaluated.

How Is the Trial Designed?

Group I: Single-fraction stereotactic radiosurgery (SRS) Experimental Treatment 1 Intervention

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.

Single-fraction stereotactic radiosurgery (SRS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stereotactic Radiosurgery for:

• Brain tumors
• Spinal tumors
• Trigeminal neuralgia
• Arteriovenous malformations
• Cancer metastases
• Pain management

Approved in European Union as Stereotactic Radiosurgery for:

• Brain tumors
• Spinal tumors
• Trigeminal neuralgia
• Arteriovenous malformations
• Cancer metastases
• Pain management

Approved in Canada as Stereotactic Radiosurgery for:

• Brain tumors
• Spinal tumors
• Trigeminal neuralgia
• Arteriovenous malformations
• Cancer metastases
• Pain management

Approved in Japan as Stereotactic Radiosurgery for:

• Brain tumors
• Spinal tumors
• Trigeminal neuralgia
• Arteriovenous malformations
• Cancer metastases
• Pain management

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

A study of 120 patients with benign spinal tumors treated with stereotactic radiosurgery (SRS) showed a very low cumulative incidence of local failure (LF) at 10 years, with rates of 12%, indicating SRS is effective for long-term tumor control.

No secondary malignancies were observed in the 776 patient-years of follow-up, suggesting that SRS is a safe treatment option for benign spinal tumors, comparable to its established use for benign intracranial tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Update of Stereotactic Radiosurgery for Benign Spinal Tumors. Chin, AL., Fujimoto, D., Kumar, KA., et al.[2020]

The implementation of the American Tax Payer Relief Act (ATRA) in 2013 led to a significant initial increase in the use of Gamma Knife stereotactic radiosurgery (SRS) over LINAC SRS for treating brain metastases, particularly in non-academic centers.

After the initial spike, LINAC SRS utilization increased again, indicating that ATRA's impact on treatment choices was temporary and highlighting how public policy can influence medical practices in the treatment of metastatic brain disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the American Tax Payer Relief Act on stereotactic radiosurgery utilization in the United States. McClelland, S., Degnin, C., Chen, Y., et al.[2020]

Hypo-fractionated gamma knife radiosurgery (hfGKRS) is an effective treatment for patients who cannot undergo single-session stereotactic radiosurgery, showing an 88% obliteration rate for complex arteriovenous malformations and a 95% five-year progression-free survival for non-AVM pathologies.

The safety profile of hfGKRS is acceptable, with radiation necrosis occurring in 8.1% of patients and radiation-induced brain edema in 12%, but no cases of radiation-induced malignancy were reported, indicating it is a safe alternative for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypo-fractionated Gamma Knife Radiosurgery for Intra-cranial Pathologies: A Single-Center Prospective Analysis of Feasibility, Safety, Efficacy, and Complication Profile. Tripathi, M., Kumar, N., Sreenivasan, SA., et al.[2023]

Spinal metastases are common and can severely affect quality of life due to pain and mobility issues, making effective treatment essential.

Stereotactic radiosurgery (SRS) offers a precise method for delivering radiation to spinal metastases, potentially improving local control and outcomes for patients, as demonstrated in a case study using advanced tomotherapy technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal metastases: case report and review of treatment options. Chawla, S., Abu-Aita, R., Philip, A., et al.[2016]

Body gamma knife stereotactic radiosurgery (ɤ-SRS) is an effective treatment for early stage non-small cell lung cancer (NSCLC), showing 5-year overall survival rates of 60.3% and progression-free survival rates of 48.8% based on a study of 29 patients over a median follow-up of 62 months.

The treatment is associated with minimized toxicity and has a median treatment cost of approximately $4,838, making it a cost-effective option that could be particularly beneficial in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Clinical Outcome With Long Term Follow-Up After Body Gamma Knife Stereotactic Radiosurgery for Patients With Early Stage Non-small Cell Lung Cancer. Li, H., Li, J., Wang, X., et al.[2023]

A case study of a 21-year-old female who underwent stereotactic radiosurgery (SRS) for a ruptured arteriovenous malformation (AVM) revealed the development of a glioblastoma (GBM) six years post-treatment, highlighting a rare but serious potential long-term risk associated with SRS.

While SRS is generally considered safe, this case underscores the importance of informing patients about the potential risk of radiation-induced malignancies, particularly glioblastomas, which can occur even years after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glioblastoma after AVM radiosurgery. Case report and review of the literature. Xhumari, A., Rroji, A., Enesi, E., et al.[2018]

Stereotactic radiosurgery (SRS) was evaluated in 44 patients with large cerebellum metastases from lung cancer, showing a median overall survival of 10.5 months and neurological progression-free survival of 9.0 months, indicating its potential efficacy in this severe condition.

After SRS treatment, 83.7% of patients experienced improvement in neurological symptoms, suggesting that SRS not only extends survival but also helps preserve neurological function in patients with large cerebellum metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for treatment of large cerebellum metastases from lung cancer. Lai, M., Li, S., Zhou, J., et al.[2021]

Stereotactic radiosurgery (SRS) is a highly effective treatment for primary and metastatic spinal tumors, achieving an 85% pain improvement rate and a 90% local control rate, which can lead to better patient outcomes.

SRS is considered safe, with a low risk of complications, such as myelopathy occurring in only 0.4% of treated patients, making it a reliable option for managing spinal neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. Chang, UK., Lee, DH.[2017]

The implementation of a safety checklist for Gamma Knife stereotactic radiosurgery (SRS) over 1500 procedures in 8 years has resulted in no reported human errors, highlighting its effectiveness in enhancing safety.

The checklist addresses specific indications for irradiating tissue volumes and functional disorders, promoting a zero-tolerance approach to errors and fostering multidisciplinary cooperation in neurosurgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lausanne checklist for safe stereotactic radiosurgery. Tuleasca, C., Zeverino, M., Patin, D., et al.[2020]

Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) have advanced significantly, necessitating updated best practices for safety and quality assurance due to their complexity and precision in delivering high doses of radiation.

A team-based approach with trained specialists and a comprehensive quality assurance program is essential for the safe and effective implementation of SRS and SBRT, emphasizing that patient safety is a collective responsibility among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. Das, IJ., Dawes, SL., Dominello, MM., et al.[2022]

In a study of 4,327 patients with brain metastases from non-small cell lung cancer, it was found that treatment at non-academic facilities significantly increased the likelihood of receiving LINAC SRS over Gamma Knife SRS, especially in the Midwestern, Northeastern, and Southern US regions.

Patients receiving higher doses of radiation (18-24 Gy) were also more likely to receive LINAC SRS, and those living within 20 miles of a treatment facility had a 27% higher chance of receiving LINAC, suggesting that geographic accessibility plays a role in treatment modality choice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. McClelland Iii, S., Degnin, C., Chen, Y., et al.[2022]

Stereotactic radiosurgery (SRS) has been shown to improve patient outcomes and reduce toxicity compared to whole-brain radiation therapy (WBRT) for treating multiple brain metastases, based on three decades of research.

Current practices allow for the treatment of patients with 10 or more brain metastases using SRS alone, even with cumulative tumor volumes of up to 25 cm³, reflecting a shift in clinical approach due to advancements in cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for Multiple Brain Metastases Radiosurgery. Niranjan, A., Monaco, E., Flickinger, J., et al.[2019]

Stereotactic radiosurgery (SRS) significantly improved overall survival (OS) for patients with multiple brain metastases, with a median OS of 15.7 months compared to 8.0 months for those receiving whole-brain radiotherapy (WBRT).

SRS also demonstrated a high local control rate of 91.7% for individual brain metastases, indicating it is an effective treatment option for managing multiple brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matched-pair analysis comparing stereotactic radiosurgery with whole-brain radiotherapy for patients with multiple brain metastases. El Shafie, RA., Celik, A., Weber, D., et al.[2021]

Stereotactic radiosurgery (SRS) for metastatic brain tumors from esophageal carcinoma showed a high local tumor control rate of 94.2% in a study of 21 patients, indicating its efficacy as a treatment option.

The treatment was safe, with no complications reported, and patients with better performance status (higher Karnofsky Performance Scale scores) had significantly increased survival, suggesting that SRS could be a viable initial treatment even for those with multiple metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for the treatment of esophageal carcinoma brain metastases. Zheng, C., Weng, Y., Xu, Q.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-peritoneal-diseases-7-2023-a88ef

SRS for Thoracoabdominal Wall Pain Stereotactic radiosurgery (SRS) has been shown to be effective in reducing pain for patients with spinal metastases, with an overall pain improvement rate of 85 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9931895/

Is single fraction the future of stereotactic body radiation ... Highlights. •. Single-session radiation treatments improve patient comfort by reducing the number of hospital visits.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-11057

Stereotactic Radiosurgery for the Treatment of Chronic ... This phase I trial tests the side effects, best dose, and feasibility of stereotactic radiosurgery (SRS) in treating patients with chronic thoracoabdominal ...

4. hca.wa.gov hca.wa.gov/assets/program/SRS-SBRT-update-lit-search-20190115.pdf

an evidence update (December 2018) Cost-effectiveness analysis of single fraction of stereotactic body radiation therapy compared with single fraction of external beam radiation therapy for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3619246/

Stereotactic Radiosurgery and Stereotactic Body Radiation ... Treatment outcomes for SRS and SBRT are usually superior or comparable, and cost-effective, relative to alternative techniques. Conclusion: Based on the review ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05985148

A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in ... Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by ...

7. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/nm/stereotactic-body-radiation-therapy-radiosurgery-nm-cs.pdf

stereotactic-body-radiation-therapy-radiosurgery- ... (2019) conducted a single-center, retrospective, case series analysis to evaluate clinical outcomes of individuals with VS and treated with SRS.