- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592887
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01)
September 6, 2023 updated by: Varian, a Siemens Healthineers Company
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45044
- Cincinnati Children's Proton Therapy Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FLASH radiotherapy for painful bone metastasis(-es)
|
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 .
|
Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.
|
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)
|
Will be assessed within 4 weeks of subject enrollment.
|
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
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Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
Toxicities will be classified per CTCAE version 5.0.
|
Assessed from start of treatment until subject death or lost to follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Assessed at Day 15, Months 1, 2, 3, long term; flare in bone pain assessed during the first 10 days after treatment
|
Use of pain medication.
Time Frame: Assessed at baseline and for the first 10 days after treatment.
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Use of pain medication.
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Assessed at baseline and for the first 10 days after treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Breneman, MD, Professor of Radiation Oncology and Neurosurgery, UCMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Maity A, Koumenis C. Shining a FLASHlight on Ultrahigh Dose-Rate Radiation and Possible Late Toxicity. Clin Cancer Res. 2022 Sep 1;28(17):3636-3638. doi: 10.1158/1078-0432.CCR-22-1255.
- Mascia AE, Daugherty EC, Zhang Y, Lee E, Xiao Z, Sertorio M, Woo J, Backus LR, McDonald JM, McCann C, Russell K, Levine L, Sharma RA, Khuntia D, Bradley JD, Simone CB 2nd, Perentesis JP, Breneman JC. Proton FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases: The FAST-01 Nonrandomized Trial. JAMA Oncol. 2023 Jan 1;9(1):62-69. doi: 10.1001/jamaoncol.2022.5843. Erratum In: JAMA Oncol. 2023 Mar 2;:
- Daugherty EC, Mascia A, Zhang Y, Lee E, Xiao Z, Sertorio M, Woo J, McCann C, Russell K, Levine L, Sharma R, Khuntia D, Bradley J, Simone CB II, Perentesis J, Breneman J. FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective Feasibility Study. JMIR Res Protoc. 2023 Jan 5;12:e41812. doi: 10.2196/41812.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2020
Primary Completion (Actual)
March 27, 2023
Study Completion (Actual)
March 27, 2023
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAR-2019-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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