Clinical trial NCT05524064: FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax
Official title: FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Metastases in the Thorax
Keywords: FLASH radiotherapy
Radiation treatment
Proton
Bone metastasis
Pain relief
Toxicities
Thorax
Ultra-high dose rate
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm prospective study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
timeFrame: Assessed from start of treatment until 6 months post treatment.
measure: Assessment of pain relief using patient reported pain questionnaire for overall pain score
timeFrame: Change from baseline pain overall at 3 months.
measure: Assessment of pain relief using patient reported pain questionnaire for pain at treated site
timeFrame: Change from baseline pain at treated site at 3 months.
measure: Use of pain medication
timeFrame: Change from baseline pain medication usage at 3 months.
Secondary outcomes:
measure: Workflow feasibility - time on table
timeFrame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
measure: Workflow feasibility - delays in study treatment
timeFrame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Healthcare Saint Francis Medical Center
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Medical Director Cincinnati Children's/UC Health Proton Therapy Center
name: John Perentesis, MD
role: PRINCIPAL_INVESTIGATOR
References: