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FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax (FAST-02)

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ClinicalTrials.gov Identifier: NCT05524064
Recruitment Status : Not yet recruiting
First Posted : September 1, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Varian, a Siemens Healthineers Company

Brief Summary:
The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Condition or disease Intervention/treatment Phase
Bone Metastases in the Thorax Radiation: FLASH Radiotherapy Not Applicable

Detailed Description:
This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single arm prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

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.
Radiation: FLASH Radiotherapy
A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (>40 Gy/s).




Primary Outcome Measures :
  1. Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. [ Time Frame: Assessed from start of treatment until 6 months post treatment. ]
    Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

  2. Assessment of pain relief using patient reported pain questionnaire for overall pain score [ Time Frame: Change from baseline pain overall at 3 months. ]
    Patient reported pain overall

  3. Assessment of pain relief using patient reported pain questionnaire for pain at treated site [ Time Frame: Change from baseline pain at treated site at 3 months. ]
    Patient reported pain at treated site

  4. Use of pain medication [ Time Frame: Change from baseline pain medication usage at 3 months. ]
    Capture dose and frequency of pain medication usage or pain medication changes.


Secondary Outcome Measures :
  1. Workflow feasibility - time on table [ Time Frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment. ]
    Total subject treatment time on table.

  2. Workflow feasibility - delays in study treatment [ Time Frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment. ]
    Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age at least 18 years
  • 1 to 3 painful bone metastasis(-es) requiring treatment, in the ribs, clavicles, scapulae, or sternum (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment).
  • Bone metastases that can be treated within a field size up to 7.5 cm x 30 cm without overlap of radiation fields
  • Life expectancy >6 months (in the judgement of the investigator)
  • Patients who are able to comply with the protocol
  • Provision of signed and dated informed consent form
  • Clinically acceptable treatment plan

Exclusion Criteria:

  • More than 3 painful bone metastases of the thorax requiring palliative radiotherapy (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment).
  • Overlap of FLASH radiation fields with any previous or planned radiation fields to the same site
  • Patients with pathologic bone fractures in the treatment field
  • Patients with metal implants in the treatment field
  • Patients with symptomatic pneumonitis at the time of screening, or a history of symptomatic radiation pneumonitis
  • Patients with known contraindications to thoracic radiation
  • Patients who received or will receive cytotoxic chemotherapy and/or any prescribed systemic therapy known to impact tissue response to radiation, within 2 weeks prior or 1 week following their planned radiation treatment
  • Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment that, in the judgement of the investigator, might compromise interpretation of pain response
  • Patients with persistent toxicity > Grade 1 from prior systemic therapy within the proposed treatment field (with the exception of alopecia and peripheral neuropathy)
  • 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 that the investigator believes to be in conflict with this clinical investigation.
  • Patients who are pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05524064


Contacts
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Contact: Jennifer Woo 437-991-3496 jennifer.woo@varian.com
Contact: Stefanie Parker 206-478-7032 stefanie.parker@varian.com

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Contact: Cincinnati Children's Hospital Medical Center-Cancer Line    513-636-2799    cancer@cchmc.org   
Principal Investigator: John Breneman, MD         
Sub-Investigator: Emily Daugherty, MD         
Sub-Investigator: John Perentesis, MD         
Sponsors and Collaborators
Varian, a Siemens Healthineers Company
Investigators
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Principal Investigator: John Breneman, MD Medical Director Cincinnati Children's/UC Health Proton Therapy Center
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Responsible Party: Varian, a Siemens Healthineers Company
ClinicalTrials.gov Identifier: NCT05524064    
Other Study ID Numbers: VAR-2022-03
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Varian, a Siemens Healthineers Company:
FLASH radiotherapy
Radiation treatment
Proton
Bone metastasis
Pain relief
Toxicities
Thorax
Ultra-high dose rate
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases