N/A
Completed N=10
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
Source: ClinicalTrials.gov NCT04592887 ↗Enrolled (actual)
10
Serious AEs
70.0%
Results posted
Jul 2024
Primary outcomePrimary: Workflow Feasibility — 15.8 minutes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Workflow Feasibility |
— | — |
| PRIMARY Assessment of Radiation-related Toxicities That Are Possibly, Probably, or Definitely Related to FLASH Radiotherapy. |
11; 1 | — |
| SECONDARY Pain Relief |
50; 16.7; 25; 8 | — |
| SECONDARY Number of Participants Who Experienced a Pain Flare. |
4 | — |
| SECONDARY Number of Participants With Increased Use of Pain Medication in First 10 Days Post FLASH Treatment |
2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04592887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.