Bone MetastasesPhase 2NCT04063254
A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
A Phase 2 study testing Stereotactic Radiotherapy in people with Bone Metastases and Radiotherapy Side Effect, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Metastases, Radiotherapy Side Effect
- What is being tested?
- Stereotactic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2019to 30 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read 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
- 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)
- Conditions
- Bone Metastases, Radiotherapy Side Effect
- Being tested
- Stereotactic Radiotherapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiotherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Stereotactic Radiotherapy | Experimental | Not described Receives: Radiation: Stereotactic Radiotherapy |
| Standard-Dose Stereotactic Radiotherapy | Active comparator | Not described Receives: Radiation: Stereotactic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063254
- Sponsor's protocol ID
- 201906063RINB
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT04063254
- Acronym / sponsor ID
- 201906063RINB
- Conditions
- Bone Metastases, Radiotherapy Side Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Stereotactic Radiotherapy | Experimental | Radiation: Stereotactic Radiotherapy |
| Standard-Dose Stereotactic Radiotherapy | Active comparator | Radiation: Stereotactic Radiotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiotherapyHigh 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). | Radiation | High-Dose Stereotactic Radiotherapy, Standard-Dose Stereotactic Radiotherapy |
Primary outcome
Effects of treatment
Time frame: 3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiotherapy in people with Bone Metastases and Radiotherapy Side Effect, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Chiang (0223123456 ext. 52802, chiangyun@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.