Back to resultsA 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
About this trial
This is an interventional treatment trial for Bone Metastases
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
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
NCT ID
NCT04063254
First Posted
August 19, 2019
Last Updated
August 19, 2019
Sponsor
National Taiwan University Hospital
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
Learn more about this trial
A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
We'll reach out to this number within 24 hrs