Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01)
|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: NCT04592887|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : August 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastasis||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 feasibility study|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases|
|Actual Study Start Date :||November 3, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: FLASH radiotherapy for painful bone metastasis(-es)||
Radiation: FLASH Radiotherapy
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
- Workflow feasibility [ Time Frame: Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment. ]Treatment for an individual subject will be deemed NOT feasible if total treatment time on table is greater than one hour .
- Workflow feasibility [ Time Frame: Will be assessed within 4 weeks of subject enrollment. ]Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 7 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)
- Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. [ Time Frame: Assessed from start of treatment until subject death or lost to follow-up ]Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
- Pain relief [ Time Frame: Assessed at Day 15, Months 1, 2, 3, long term; flare in bone pain assessed during the first 10 days after treatment ]Patient reported pain score overall and specifically for treated sites.
- Use of pain medication. [ Time Frame: Assessed at baseline and for the first 10 days after treatment. ]Use of pain medication.
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): NCT04592887
|United States, Ohio|
|Cincinnati Children's Proton Therapy Center||Recruiting|
|Cincinnati, Ohio, United States, 45044|
|Contact: Cincinnati Children's Hospital Medical Center-Cancer Line 513-636-2799 email@example.com|
|Principal Investigator:||John Breneman, MD||Professor of Radiation Oncology and Neurosurgery, UCMC|