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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592887
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Varian, a Siemens Healthineers Company

Tracking Information
First Submitted Date  ICMJE October 5, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE November 3, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Bone Metastasis
Intervention  ICMJE Radiation: FLASH Radiotherapy
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
Study Arms  ICMJE Experimental: FLASH radiotherapy for painful bone metastasis(-es)
Intervention: Radiation: FLASH Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 15, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592887
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Varian, a Siemens Healthineers Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Varian, a Siemens Healthineers Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Breneman, MD Professor of Radiation Oncology and Neurosurgery, UCMC
PRS Account Varian, a Siemens Healthineers Company
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP