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

NCT ID: NCT05524064

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2027-05-01

Brief 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.

Conditions

Bone Metastases in the Thorax

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLASH radiotherapy for painful bone metastasis(-es)

FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Group Type: EXPERIMENTAL

FLASH Radiotherapy

Intervention Type: RADIATION

A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

Interventions

FLASH Radiotherapy

A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian, a Siemens Healthineers Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Perentesis, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director Cincinnati Children's/UC Health Proton Therapy Center

Locations

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

Daugherty EC, Zhang Y, Xiao Z, Mascia AE, Sertorio M, Woo J, McCann C, Russell KJ, Sharma RA, Khuntia D, Bradley JD, Simone CB 2nd, Breneman JC, Perentesis JP. FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach. Radiat Oncol. 2024 Mar 12;19(1):34. doi: 10.1186/s13014-024-02419-4.

Reference Type: DERIVED

PMID: 38475815 (View on PubMed)

Other Identifiers

VAR-2022-03

Identifier Type: -

Identifier Source: org_study_id