Bone MetastasisFAST-01NCT04592887
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
A study testing FLASH Radiotherapy in people with Bone Metastasis, run by Varian, a Siemens Healthineers Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- FLASH Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Proton Therapy Center
Cincinnati, Ohio, 45044
About this study
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.
Read the 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.
- Conditions
- Bone Metastasis
- Being tested
- FLASH Radiotherapy
- Keywords
- FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Feasibility study, Pain relief, Toxicities, Extremities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLASH RadiotherapyRadiation
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| FLASH radiotherapy for painful bone metastasis(-es) | Experimental | Not described Receives: Radiation: FLASH Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workflow Feasibility
Number of participants with total time on table under one hour. The investigational site staff will measure the time for participant set-up and positioning on the treatment couch, imaging and FLASH treatment delivery. The workflow feasibility outcome measure is met for an individual subject if total time on table is measured as less than one hour.
The outcome measure data table provides the mean and full range of time on table (as measured in minutes) for the 10 participants. The participant with a treatment time of 33 minutes received treatment to two separate metastatic sites; remaining 9 participants received treatment to a single metastatic site.
Measured: Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.
Workflow Feasibility
Number of participants whose treatment was delayed by more than 7 business days from simulation to treatment when related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).
The investigational site staff will measure the number of days delay in time to treatment due to problems involving the investigational device. The workflow feasibility outcome measure is met for an individual subject if the delay is measured as less than 7 days.
The outcome measure data table provides the mean and full range days of treatment delay for the 10 participants.
Measured: Will be assessed within 4 weeks of subject enrollment.
Assessment of Radiation-related Toxicities That Are Possibly, Probably, or Definitely Related to FLASH Radiotherapy.
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
The outcome measure data table summarizes the total number of adverse events possibly, probably, definitely related to treatment that were reported in the 10 participant cohort. Eleven adverse events were grade 1 and one adverse event was grade 2, as classified by CTCAE version 5.0.
Measured: Assessed from start of treatment until subject death or lost to follow-up, up to 17.8 months
Secondary outcomes (3)
Pain Relief
Percentage of treated sites achieving pain relief as measured using patient reported outcome questionnaires (Brief Pain Inventory Questionnaire, Treated Sites Pain Questionnaire). Categories of pain relief included complete, partial, stable or progressive response.
Complete response (CR) = no pain at 3 months Partial response (PR) = an average pain score that is ≥2 points lower than initial Stable disease (SD) = an average pain score that is ±1 point change from initial Progressive disease (PD) = an average pain score that is ≥2 points higher than initial
Measured: At 3 month follow up
Number of Participants Who Experienced a Pain Flare.
Pain was assessed by patient reported validated 10 point pain flare questionnaire. Pain flare is defined as either of the following: A) a minimum of a two-point increase in the worst pain score for the treated site without a reduction in analgesic intake; or B) a 25% or greater increase in analgesic intake based on daily oral morphine equivalence without a reduction in the worst pain score.
Measured: First 10 days post FLASH treatment
Number of Participants With Increased Use of Pain Medication in First 10 Days Post FLASH Treatment
Use of pain medication by study participant during days 1-10 following FLASH treatment was collected as it constituted one of the defining criteria (criteria B) for the pain flare outcome measure.
Pain flare is defined as either of the following: A) a minimum of a two-point increase in the worst pain score for the treated site without a reduction in analgesic intake; or B) a 25% or greater increase in analgesic intake based on daily oral morphine equivalence without a reduction in the worst pain score.
Measured: Within 10 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Nov 2020
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm prospective feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Breneman, MD, Principal investigator, Professor of Radiation Oncology and Neurosurgery, UCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592887
- Sponsor's protocol ID
- VAR-2019-02
- Acronym
- FAST-01
- Status last verified
- Jul 2024
- First submitted
- 5 Oct 2020
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36273324Daugherty 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 2nd, 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.
PubMed 36206189Maity 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.
PubMed 35736814
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
- ClinicalTrials.gov ID
- NCT04592887
- Acronym / sponsor ID
- FAST-01 / VAR-2019-02
- Conditions
- Bone Metastasis
- Keywords
- FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Feasibility study, Pain relief, Toxicities, Extremities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm prospective feasibility study
| Arm | Type | Receives |
|---|---|---|
| FLASH radiotherapy for painful bone metastasis(-es) | Experimental | Radiation: FLASH Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLASH RadiotherapyFLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment. | Radiation | FLASH radiotherapy for painful bone metastasis(-es) |
Primary outcome
Workflow Feasibility
Time frame: Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.
Number of participants with total time on table under one hour. The investigational site staff will measure the time for participant set-up and positioning on the treatment couch, imaging and FLASH treatment delivery. The workflow feasibility outcome measure is met for an individual subject if total time on table is measured as less than one hour. The outcome measure data table provides the mean and full range of time on table (as measured in minutes) for the 10 participants. The participant with a treatment time of 33 minutes received treatment to two separate metastatic sites; remaining 9 participants received treatment to a single metastatic site.
Workflow Feasibility
Time frame: Will be assessed within 4 weeks of subject enrollment.
Number of participants whose treatment was delayed by more than 7 business days from simulation to treatment when related to the investigational device (excluding delays due to patient or facility factors not related to study treatment). The investigational site staff will measure the number of days delay in time to treatment due to problems involving the investigational device. The workflow feasibility outcome measure is met for an individual subject if the delay is measured as less than 7 days. The outcome measure data table provides the mean and full range days of treatment delay for the 10 participants.
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, up to 17.8 months
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0. The outcome measure data table summarizes the total number of adverse events possibly, probably, definitely related to treatment that were reported in the 10 participant cohort. Eleven adverse events were grade 1 and one adverse event was grade 2, as classified by CTCAE version 5.0.
3 secondary outcomes
Pain Relief
Time frame: At 3 month follow up
Number of Participants Who Experienced a Pain Flare.
Time frame: First 10 days post FLASH treatment
Number of Participants With Increased Use of Pain Medication in First 10 Days Post FLASH Treatment
Time frame: Within 10 days after treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36273324Mascia 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.
- Derived from this study: PubMed 36206189Daugherty 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 2nd, 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.
- Derived from this study: PubMed 35736814Maity 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.
- Individual participant dataSharing planned: No
Related trials for Bone Metastasis
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Breneman, MD principal investigator
Professor of Radiation Oncology and Neurosurgery, UCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLASH Radiotherapy in people with Bone Metastasis, run by Varian, a Siemens Healthineers Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Workflow Feasibility (time frame: Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592887, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.