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

Primary Purpose

Bone Metastases in the Thorax

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FLASH Radiotherapy

About this trial

This is an interventional treatment trial for Bone Metastases in the Thorax focused on measuring FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Pain relief, Toxicities, Thorax, Ultra-high dose rate

Eligibility Criteria

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

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

Sites / Locations

Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLASH radiotherapy for painful bone metastasis(-es)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Assessment of pain relief using patient reported pain questionnaire for overall pain score

Patient reported pain overall

Assessment of pain relief using patient reported pain questionnaire for pain at treated site

Patient reported pain at treated site

Use of pain medication

Capture dose and frequency of pain medication usage or pain medication changes.

Secondary Outcome Measures

Workflow feasibility - time on table

Total subject treatment time on table.

Workflow feasibility - delays in study treatment

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).

Full Information

NCT ID

NCT05524064

First Posted

August 21, 2022

Last Updated

March 18, 2023

Sponsor

Varian, a Siemens Healthineers Company

1. Study Identification

Unique Protocol Identification Number

NCT05524064

Brief Title

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

Acronym

FAST-02

Official Title

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2023 (Actual)

Primary Completion Date

April 1, 2025 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

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

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

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases in the Thorax

Keywords

FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Pain relief, Toxicities, Thorax, Ultra-high dose rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open label, single arm prospective study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FLASH radiotherapy for painful bone metastasis(-es)

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

FLASH Radiotherapy

Intervention Description

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 Measure Information:

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 6 months post treatment.

Title

Assessment of pain relief using patient reported pain questionnaire for overall pain score

Description

Patient reported pain overall

Time Frame

Change from baseline pain overall at 3 months.

Title

Assessment of pain relief using patient reported pain questionnaire for pain at treated site

Description

Patient reported pain at treated site

Time Frame

Change from baseline pain at treated site at 3 months.

Title

Use of pain medication

Description

Capture dose and frequency of pain medication usage or pain medication changes.

Time Frame

Change from baseline pain medication usage at 3 months.

Secondary Outcome Measure Information:

Title

Workflow feasibility - time on table

Description

Total subject treatment time on table.

Time Frame

Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

Title

Workflow feasibility - delays in study treatment

Description

Time Frame

Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Woo

Phone

437-991-3496

jennifer.woo@varian.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stefanie Parker

Phone

206-478-7032

stefanie.parker@varian.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Breneman, MD

Organizational Affiliation

Medical Director Cincinnati Children's/UC Health Proton Therapy Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cincinnati Children's Hospital Medical Center-Cancer Line

Phone

513-636-2799

cancer@cchmc.org

First Name & Middle Initial & Last Name & Degree

John Breneman, MD

First Name & Middle Initial & Last Name & Degree

Emily Daugherty, MD

First Name & Middle Initial & Last Name & Degree

John Perentesis, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

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