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

NCT04592887 | Completed Results DMC FDA Device

• 1 other identifier: VAR-2019-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastasis

Keywords

FLASH radiotherapy; Radiation treatment; Proton; Bone metastasis; Feasibility study; Pain relief; Toxicities; Extremities

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed from start of treatment until subject death or lost to follow-up, up to 17.8 months

Secondary Outcomes (3)

• Pain Relief

  At 3 month follow up

• Number of Participants Who Experienced a Pain Flare.

  First 10 days post FLASH treatment

• Number of Participants With Increased Use of Pain Medication in First 10 Days Post FLASH Treatment

  Within 10 days after treatment.

Study Arms (1)

FLASH radiotherapy for painful bone metastasis(-es)

EXPERIMENTAL

Radiation: FLASH Radiotherapy

Interventions

FLASH Radiotherapy RADIATION

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

FLASH radiotherapy for painful bone metastasis(-es)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Cincinnati Children's Proton Therapy Center

Cincinnati, Ohio, 45044, United States

Location

Related Publications (3)

• 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.

  PMID: 36273324 DERIVED

• 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 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.

  PMID: 36206189 DERIVED

• 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.

  PMID: 35736814 DERIVED

Results Point of Contact

• Title: Senior Manager, Clinical Trials
• Organization: Varian, a Siemens Healthineers Company

ClinOps@varian.com

437-991-3496

Study Officials

• John Breneman, MD

  Professor of Radiation Oncology and Neurosurgery, UCMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm prospective feasibility study

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: November 3, 2020
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)