FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

Trial Title: FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

NCT ID: NCT05524064

Condition: Bone Metastases in the Thorax

Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases

Conditions: Keywords:
FLASH radiotherapy
Radiation treatment
Proton
Bone metastasis
Pain relief
Toxicities
Thorax
Ultra-high dose rate

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Open label, single arm prospective study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: FLASH Radiotherapy
Description: A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (>40 Gy/s).
Arm group label: FLASH radiotherapy for painful bone metastasis(-es)

Summary: The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Detailed description: This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patient age at least 18 years - 1 to 3 painful bone metastasis(-es) requiring treatment, in the ribs, clavicles, scapulae, or sternum (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment). - Bone metastases that can be treated within a field size up to 7.5 cm x 30 cm without overlap of radiation fields - Life expectancy >6 months (in the judgement of the investigator) - Patients who are able to comply with the protocol - Provision of signed and dated informed consent form - Clinically acceptable treatment plan Exclusion Criteria: - More than 3 painful bone metastases of the thorax requiring palliative radiotherapy (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment). - Overlap of FLASH radiation fields with any previous or planned radiation fields to the same site - Patients with pathologic bone fractures in the treatment field - Patients with metal implants in the treatment field - Patients with symptomatic pneumonitis at the time of screening, or a history of symptomatic radiation pneumonitis - Patients with known contraindications to thoracic radiation - Patients who received or will receive cytotoxic chemotherapy and/or any prescribed systemic therapy known to impact tissue response to radiation, within 2 weeks prior or 1 week following their planned radiation treatment - Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment that, in the judgement of the investigator, might compromise interpretation of pain response - Patients with persistent toxicity > Grade 1 from prior systemic therapy within the proposed treatment field (with the exception of alopecia and peripheral neuropathy) - Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy - Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation - Patients at known risk of enhanced normal tissue sensitivity to radiotherapy due to inherited predisposition or documented comorbidity that might lead to hypersensitivity to ionizing radiation - Patients enrolled in any other clinical studies that the investigator believes to be in conflict with this clinical investigation. - Patients who are pregnant or nursing

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cincinnati Children's Hospital Medical Center

Address:
City: Cincinnati
Zip: 45229
Country: United States

Status: Recruiting

Contact:
Last name: Cincinnati Children's Hospital Medical Center-Cancer Line

Phone: 513-636-2799
Email: cancer@cchmc.org

Investigator:
Last name: John Breneman, MD
Email: Principal Investigator

Investigator:
Last name: Emily Daugherty, MD
Email: Sub-Investigator

Investigator:
Last name: John Perentesis, MD
Email: Sub-Investigator

Start date: March 8, 2023

Completion date: April 1, 2025

Lead sponsor:
Agency: Varian, a Siemens Healthineers Company
Agency class: Industry

Source: Varian, a Siemens Healthineers Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05524064