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Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01)

Primary Purpose

Bone Metastasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FLASH Radiotherapy
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastasis focused on measuring FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Feasibility study, Pain relief, Toxicities, Extremities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Proton Therapy Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLASH radiotherapy for painful bone metastasis(-es)

Arm Description

Outcomes

Primary Outcome Measures

Workflow feasibility
Treatment for an individual subject will be deemed NOT feasible if total treatment time on table is greater than one hour .
Workflow feasibility
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.
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

Secondary Outcome Measures

Pain relief
Patient reported pain score overall and specifically for treated sites.
Use of pain medication.
Use of pain medication.

Full Information

First Posted
October 5, 2020
Last Updated
September 6, 2023
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT04592887
Brief Title
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
Acronym
FAST-01
Official Title
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
March 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastasis
Keywords
FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Feasibility study, Pain relief, Toxicities, Extremities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label, single arm prospective feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLASH radiotherapy for painful bone metastasis(-es)
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
FLASH Radiotherapy
Intervention Description
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
Primary Outcome Measure Information:
Title
Workflow feasibility
Description
Treatment for an individual subject will be deemed NOT feasible if total treatment time on table is greater than one hour .
Time Frame
Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.
Title
Workflow feasibility
Description
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)
Time Frame
Will be assessed within 4 weeks of subject enrollment.
Title
Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
Description
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
Time Frame
Assessed from start of treatment until subject death or lost to follow-up
Secondary Outcome Measure Information:
Title
Pain relief
Description
Patient reported pain score overall and specifically for treated sites.
Time Frame
Assessed at Day 15, Months 1, 2, 3, long term; flare in bone pain assessed during the first 10 days after treatment
Title
Use of pain medication.
Description
Use of pain medication.
Time Frame
Assessed at baseline and for the first 10 days after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Breneman, MD
Organizational Affiliation
Professor of Radiation Oncology and Neurosurgery, UCMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Proton Therapy Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36273324
Citation
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;:
Results Reference
derived
PubMed Identifier
36206189
Citation
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.
Results Reference
derived
PubMed Identifier
35736814
Citation
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.
Results Reference
derived

Learn more about this trial

Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases

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