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

NCT05524064 | Active Not Recruiting DMC FDA Device

• 1 other identifier: VAR-2022-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Metastases in the Thorax

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.

  Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

  Assessed from start of treatment until 6 months post treatment.

• Assessment of pain relief using patient reported pain questionnaire for overall pain score

  Patient reported pain overall

  Change from baseline pain overall at 3 months.

• Assessment of pain relief using patient reported pain questionnaire for pain at treated site

  Patient reported pain at treated site

  Change from baseline pain at treated site at 3 months.

• Use of pain medication

  Capture dose and frequency of pain medication usage or pain medication changes.

  Change from baseline pain medication usage at 3 months.

Secondary Outcomes (2)

• Workflow feasibility - time on table

  Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

• Workflow feasibility - delays in study treatment

  Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

Study Arms (1)

FLASH radiotherapy for painful bone metastasis(-es)

EXPERIMENTAL

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

Radiation: FLASH Radiotherapy

Interventions

FLASH Radiotherapy RADIATION

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

FLASH radiotherapy for painful bone metastasis(-es)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age at least 18 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (2)

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 38475815 DERIVED

Study Officials

• John Perentesis, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm prospective study

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: September 1, 2022
• Study Start: March 8, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)