FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax (NCT05524064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax
United States10 participantsStarted 2023-03-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 plan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
Assessment of pain relief using patient reported pain questionnaire for overall pain score
Timeframe: Change from baseline pain overall at 3 months.
3
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.
4
Use of pain medication
Timeframe: Change from baseline pain medication usage at 3 months.