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

• ClinicalTrials.gov Identifier: NCT04592887
• Recruitment Status: Active, not recruiting
• First Posted: October 19, 2020
• Last Update Posted: November 1, 2021
• Sponsor: Varian, a Siemens Healthineers Company
• Information provided by (Responsible Party): Varian, a Siemens Healthineers Company

Tracking Information

• First Submitted Date: October 5, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: November 1, 2021
• Actual Study Start Date: November 3, 2020
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2020)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 15, 2020)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
• Official Title: Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open label, single arm prospective feasibility study

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Bone Metastasis

Intervention

Radiation: FLASH Radiotherapy

FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Study Arms

Experimental: FLASH radiotherapy for painful bone metastasis(-es)

Intervention: Radiation: FLASH Radiotherapy

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. 2022 Oct 23:e225843. doi: 10.1001/jamaoncol.2022.5843. Online ahead of print.
• 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 Ii CB, 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 15, 2020): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04592887
• Other Study ID Numbers: VAR-2019-02
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Varian, a Siemens Healthineers Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Varian, a Siemens Healthineers Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: John Breneman, MD; Professor of Radiation Oncology and Neurosurgery, UCMC

• PRS Account: Varian, a Siemens Healthineers Company
• Verification Date: October 2021