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A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases

Primary Purpose

Bone Metastases, Radiotherapy Side Effect

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Stereotactic Radiotherapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with a histologic diagnosis of non-hematopoietic malignancy
  2. Radiographic evidence of bone metastases
  3. Patient with pain or dysathesia on a pain score of at least 2 by brief pain inventory survey
  4. Multiple osseous sites are eligible with a maximum of three separate sites irradiated concurrently
  5. Patients do not have prior radiotherapy or radiosurgery to the index site(s)
  6. Age ≥ 20 years
  7. Karnofsky performance status (KPS) ≥ 50%.
  8. Life expectancy of ≥ 3 months
  9. Women of childbearing potential and male participants must practice adequate contraception
  10. Patients must be able to comply with the study protocol, pain assessment, quality of life survey, and follow-up schedules and provide study-specific informed consent

Exclusion Criteria:

  1. Patients with radiographic impending or pathological fracture, or malignant epidural cord compression at the index site(s) indicative of upfront surgery
  2. Prior radiotherapy or radiosurgery to the index site(s)
  3. Previously treated with radioactive isotope (e.g. Ra-223) within 30 days of registration
  4. Inability to cooperate treatment procedure
  5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

    1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
    2. Transmural myocardial infarction ≤ 6 months prior to registration
    3. Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
    4. Life-threatening uncontrolled clinically significant cardiac arrhythmias
    5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    7. Uncontrolled psychiatric disorder
  6. Will receive any other investigational agent or chemotherapy during treatment
  7. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
  8. Pregnant or breast-feeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    High-Dose Stereotactic Radiotherapy

    Standard-Dose Stereotactic Radiotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Effects of treatment
    To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2019
    Last Updated
    August 19, 2019
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04063254
    Brief Title
    A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
    Official Title
    A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 30, 2019 (Anticipated)
    Primary Completion Date
    August 30, 2021 (Anticipated)
    Study Completion Date
    August 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the present study, we will prospectively evaluate the pain response and treatment failure rate to determine the most favorable radiation dose in single fraction stereotactic radiotherapy using the modern highly conformal technique for bone metastases. Our findings should be able to provide evidence-based recommendation to support the utilization of single fraction radiotherapy for value-based oncology practice.
    Detailed Description
    Primary objective To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events, at 3 months Worsening in the worst pain score by at least 3 by brief pain inventory survey ≥ 50% increase in dose of opioid/narcotic medication Development of pathologic fracture or cord/nerve compression indicative of surgical intervention Unequivocal radiographic disease progression Secondary objectives Compare pain response/control at the treated site(s) between the two treatment regimens by brief pain inventory survey Assess health-related quality of life for palliative cancer care patients (EORTC QLQ-C15-PAL & EORTC-BM22 Mandarin Taiwan) Evaluate the analgescis use after irradiation Evaluate acute and late adverse events associated with irradiation according to CTCAE criteria To evaluate the local control of the treated index site(s) To evaluate the patterns of failure To evlaute overall survival To evaluate the rate of re-irradiation, salvage surgery, interventional procedure, and MR-guided high intensity focused ultrasound at the treated site(s)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Metastases, Radiotherapy Side Effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    302 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-Dose Stereotactic Radiotherapy
    Arm Type
    Experimental
    Arm Title
    Standard-Dose Stereotactic Radiotherapy
    Arm Type
    Active Comparator
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic Radiotherapy
    Intervention Description
    High Dose (Arm A): Stereotactic radiotherapy with 12 or 16 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Standard-dose (Arm B): Stereotactic radiotherapy with 8 or 10 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).
    Primary Outcome Measure Information:
    Title
    Effects of treatment
    Description
    To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with a histologic diagnosis of non-hematopoietic malignancy Radiographic evidence of bone metastases Patient with pain or dysathesia on a pain score of at least 2 by brief pain inventory survey Multiple osseous sites are eligible with a maximum of three separate sites irradiated concurrently Patients do not have prior radiotherapy or radiosurgery to the index site(s) Age ≥ 20 years Karnofsky performance status (KPS) ≥ 50%. Life expectancy of ≥ 3 months Women of childbearing potential and male participants must practice adequate contraception Patients must be able to comply with the study protocol, pain assessment, quality of life survey, and follow-up schedules and provide study-specific informed consent Exclusion Criteria: Patients with radiographic impending or pathological fracture, or malignant epidural cord compression at the index site(s) indicative of upfront surgery Prior radiotherapy or radiosurgery to the index site(s) Previously treated with radioactive isotope (e.g. Ra-223) within 30 days of registration Inability to cooperate treatment procedure Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows: Uncontrolled active infection requiring intravenous antibiotics at the time of registration Transmural myocardial infarction ≤ 6 months prior to registration Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration Life-threatening uncontrolled clinically significant cardiac arrhythmias Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Uncontrolled psychiatric disorder Will receive any other investigational agent or chemotherapy during treatment Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic Pregnant or breast-feeding women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun Chiang
    Phone
    0223123456
    Ext
    52802
    Email
    chiangyun@ntuh.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases

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