FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax (FAST-02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05524064|
Recruitment Status : Not yet recruiting
First Posted : September 1, 2022
Last Update Posted : September 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases in the Thorax||Radiation: FLASH Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, single arm prospective study|
|Masking:||None (Open Label)|
|Official Title:||FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax|
|Estimated Study Start Date :||October 1, 2022|
|Estimated Primary Completion Date :||April 1, 2025|
|Estimated Study Completion Date :||April 1, 2025|
Experimental: FLASH radiotherapy for painful bone metastasis(-es)
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
Radiation: FLASH Radiotherapy
A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (>40 Gy/s).
- Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. [ Time Frame: Assessed from start of treatment until 6 months post treatment. ]Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
- Assessment of pain relief using patient reported pain questionnaire for overall pain score [ Time Frame: Change from baseline pain overall at 3 months. ]Patient reported pain overall
- Assessment of pain relief using patient reported pain questionnaire for pain at treated site [ Time Frame: Change from baseline pain at treated site at 3 months. ]Patient reported pain at treated site
- Use of pain medication [ Time Frame: Change from baseline pain medication usage at 3 months. ]Capture dose and frequency of pain medication usage or pain medication changes.
- Workflow feasibility - time on table [ Time Frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment. ]Total subject treatment time on table.
- Workflow feasibility - delays in study treatment [ Time Frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment. ]Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05524064
|Contact: Jennifer Wooemail@example.com|
|Contact: Stefanie Parkerfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Contact: Cincinnati Children's Hospital Medical Center-Cancer Line 513-636-2799 email@example.com|
|Principal Investigator: John Breneman, MD|
|Sub-Investigator: Emily Daugherty, MD|
|Sub-Investigator: John Perentesis, MD|
|Principal Investigator:||John Breneman, MD||Medical Director Cincinnati Children's/UC Health Proton Therapy Center|