Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01)

Varian

Status

Completed

Conditions

Bone Metastasis

Treatments

Radiation: FLASH Radiotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04592887

VAR-2019-02

Details and patient eligibility

About

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.

Full description

This clinical investigation is designed to assess the workflow feasibility of FLASH radiotherapy treatment in a clinical setting, as well as the toxicities, and pain relief when used to treat bone metastasis(-es) in the extremities (excluding feet, hands, wrists). FLASH radiotherapy has been shown in preclinical studies to cause less injury to surrounding normal tissues during radiation treatment, while still having similar tumor cell killing. Patients at least 18 years of age with painful bone metastases located in the limbs will be considered for the study. These patients represent an ideal population for a feasibility study of FLASH radiotherapy as they are known to benefit from the palliative effects of radiotherapy using single dose radiation regimens of 8Gy which is what is being used in this investigation. After treatment, patients will be assessed for pain response as well as any adverse side-effects of radiation. The workflow feasibility of the treatment will also be evaluated.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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