Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases

Completed · Not applicable

Conditions studied: Bone Metastasis

In brief

This purpose of this study is to assess the feasibility of FLASH radiotherapy for the palliative treatment of painful bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Key facts

Study ID

NCT04592887

Run by

Varian, a Siemens Healthineers Company

People needed

10

Starts

2020-11-03

Expected to finish

2023-03-27

Last updated by the study team

2024-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age at least 18 years
• Up to 3 painful bone metastasis(-es) in the extremities
• Bone metastases that can be treated using pre-defined treatment field sizes (7.5 cm x 7.5 cm; 7.5 cm x 10 cm; 7.5 cm x 12 cm; 7.5 cm x 14 cm; 7.5 cm x 16 cm; 7.5 cm x 18 cm; 7.5 cm x 20 cm), without overlap of radiation fields
• Life expectancy of >2 months (in the judgement of the investigator)
• Patients who are able to comply with the protocol
• Provision of signed and dated informed consent form

You may not qualify if…

• Prior radiotherapy to the treatment site(s)
• Lesions of the feet, hands, wrists are not eligible treatment sites for FLASH
• More than 3 painful bone metastases of the limbs requiring palliative radiotherapy
• Tumor lysis of >50% of the circumferential bone cortex, or other factors considered to place the subject at significant risk of pathologic fracture
• Patients with bone fractures and/or metal implants in the treatment field
• Patients who will receive cytotoxic chemotherapy within 1 week prior to or 1 week following their planned radiation treatment
• Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment
• 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 the investigator believes to be in conflict with this clinical investigation.
• Patients who are pregnant or nursing

Where it is running

• Cincinnati Children's Proton Therapy Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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