Status:
UNKNOWN
A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Bone Metastases
Radiotherapy Side Effect
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 ...
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 1. Worsening in the wors...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2021
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT04063254
Start Date
August 30 2019
End Date
August 30 2021
Last Update
August 21 2019
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