Metastatic Bone LesionNCT02145286
Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow
A study testing Stereotactic Body Radiation Therapy in people with Metastatic Bone Lesion, run by Paul W. Read, MD at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bone Lesion
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has 1-3 major painful osseous metastases (target lesions)
- Radiographic evidence (CT, MR, or PET CT) consistent with osseous metastatic disease on CT, MR, or PET CT obtained within 4 weeks of treatment will be used for pre-study treatment delivery. The GTV of the target lesions will be determined from this radiographic study and must be ≤ 250 cubic centimeters.
- NOTE: Patient is still eligible if a diagnostic image set is not available within 4 weeks of treatment if the patient will undergo a kVCT simulation in the Department of Radiation Oncology with contouring directly onto this image set.
- Patient is medically able to undergo palliative radiation therapy
- Patient has pain that is persistent and distinguishably associated with the target sites to be treated
- Planning Target Volume 1 (PTV1) must be > 5mm from the spinal cord or brain
- Women of Childbearing age and men must consent to use adequate contraception for six months following study entry
Who cannot join
- Inability to lie on the treatment table for 1 hour
- Systemic therapeutic radionuclide delivery within 30 days prior to treatment
- Target lesions have been previously treated with external beam radiation
- Long bone target lesions with a Mirels fracture score >7
- Unstable bone in the target lesion requiring surgical stabilization
- PTV1 is located within 5mm of spinal cord or brain
- A serious, uncontrolled medical disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Phase I/II Single Arm Prospective Single Fraction Real-time Stereotactic Body Radiation Therapy Dose Escalation Trial of Rapid Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease
The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones). In this trial a single fraction of radiation will be given from 8-15 Gray.
Read the detailed description
The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones).
Focused radiation (the radiation is focused on the tumor in the bone with reduced radiation dose to the normal tissues) is used as standard of care treatment for patients with painful metastatic tumors in their spines with just one treatment. In this study, the focused radiation will be used to treat tumors in other bones as well. The current standard of care radiation treatment planning and delivery can take 2 to 3 weeks from start to finish depending on how many treatments are given although the standard of care is to treat patients with 1-10 treatments. The University of Virginia has developed an experimental workflow/process: a radiation treatment planning and delivery workflow called "STAT RAD" (STAT means "right away", and RAD means radiation). This experimental workflow will shorten the time it takes to plan and treat painful bone metastases to 1-2 hours.
When only one treatment is given the standard radiation dose is 8 Gray. This has resulted in radiation retreatment rates to the treated bone of 20% in prior studies for persistent or recurrent bone pain. In this study patients will be treated with higher doses of targeted radiation to determine if higher doses, which have been reported to be safely delivered for bone metastases in the spine with very low re-treatment rates, can be safely delivered to non-spine bone metastases. After the treatment, patients will be followed for pain relief in the treated bone, need for pain medication, quality of life, toxicity, and the need to retreat the bone metastasis for persistent or recurrent pain.
- Conditions
- Metastatic Bone Lesion
- Being tested
- Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
SBRT is a high dose and highly conformal radiation dose treatment with the goal of rapid tumor killing and/or ablation of tumors
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Stereotactic Body Radiation Therapy Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dose
Determine the optimal dose range for treatment of osseous bone metastases with single SBRT (Stereotactic Body Radiation Therapy) treatment using the STAT RAD (right away/radiation) workflow
Measured: Up to 12 months following treatment
Secondary outcomes (3)
Single Treatment Pain Scores
Patients will complete questionnaires to determine whether the treatment of osseous bone metastases with single treatment using the STAT RAD workflow results in a significant change in pain scores at 4 weeks following treatment of patients with good prognosis, compared to baseline scores
Measured: Up to 4 weeks following treatment
Paired Dose Pain Score Comparison
Patient questionnaires will be used to estimate the difference in the mean change in pain score from baseline to 4 weeks following treatment of patients with good prognosis between pairs of dose levels among those in the range of optimal doses
Measured: Up to 4 weeks following treatment
Post Treatment Measures
Patients will complete questionnaires to capture pain scores of the treated lesion(s), analgesic use, patient functional status, patient quality of life, and patient satisfaction at 1,4,8, and 12 weeks and at 6 and 12 months following treatment. Rates of radiation-retreatment within one year will also be captured for the treated target lesion(s).
Measured: Up to 12 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Bone LesionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul W. Read, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul W. Read, MD, University of Virginia
- Investigators
- Paul W Read, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145286
- Sponsor's protocol ID
- 16964
- Status last verified
- Jun 2018
- First submitted
- 19 May 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Single Arm Prospective Single Fraction Real-time Stereotactic Body Radiation Therapy Dose Escalation Trial of Rapid Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease
- ClinicalTrials.gov ID
- NCT02145286
- Acronym / sponsor ID
- 16964
- Conditions
- Metastatic Bone Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Paul W. Read, MDUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 22 May 2014 (estimated)
- 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.
The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones). In this trial a single fraction of radiation will be given from 8-15 Gray.
Detailed description
The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones).
Focused radiation (the radiation is focused on the tumor in the bone with reduced radiation dose to the normal tissues) is used as standard of care treatment for patients with painful metastatic tumors in their spines with just one treatment. In this study, the focused radiation will be used to treat tumors in other bones as well. The current standard of care radiation treatment planning and delivery can take 2 to 3 weeks from start to finish depending on how many treatments are given although the standard of care is to treat patients with 1-10 treatments. The University of Virginia has developed an experimental workflow/process: a radiation treatment planning and delivery workflow called "STAT RAD" (STAT means "right away", and RAD means radiation). This experimental workflow will shorten the time it takes to plan and treat painful bone metastases to 1-2 hours.
When only one treatment is given the standard radiation dose is 8 Gray. This has resulted in radiation retreatment rates to the treated bone of 20% in prior studies for persistent or recurrent bone pain. In this study patients will be treated with higher doses of targeted radiation to determine if higher doses, which have been reported to be safely delivered for bone metastases in the spine with very low re-treatment rates, can be safely delivered to non-spine bone metastases. After the treatment, patients will be followed for pain relief in the treated bone, need for pain medication, quality of life, toxicity, and the need to retreat the bone metastasis for persistent or recurrent pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Stereotactic Body Radiation TherapyStereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has 1-3 major painful osseous metastases (target lesions)
- Radiographic evidence (CT, MR, or PET CT) consistent with osseous metastatic disease on CT, MR, or PET CT obtained within 4 weeks of treatment will be used for pre-study treatment delivery. The GTV of the target lesions will be determined from this radiographic study and must be ≤ 250 cubic centimeters.
- NOTE: Patient is still eligible if a diagnostic image set is not available within 4 weeks of treatment if the patient will undergo a kVCT simulation in the Department of Radiation Oncology with contouring directly onto this image set.
- Patient is medically able to undergo palliative radiation therapy
- Patient has pain that is persistent and distinguishably associated with the target sites to be treated
Key exclusion criteria (8 listed)
- Inability to lie on the treatment table for 1 hour
- Systemic therapeutic radionuclide delivery within 30 days prior to treatment
- Target lesions have been previously treated with external beam radiation
- Long bone target lesions with a Mirels fracture score >7
- Unstable bone in the target lesion requiring surgical stabilization
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 Body Radiation TherapySBRT is a high dose and highly conformal radiation dose treatment with the goal of rapid tumor killing and/or ablation of tumors | Radiation | Radiation Therapy |
Primary outcome
Radiation Dose
Time frame: Up to 12 months following treatment
Determine the optimal dose range for treatment of osseous bone metastases with single SBRT (Stereotactic Body Radiation Therapy) treatment using the STAT RAD (right away/radiation) workflow
3 secondary outcomes
Single Treatment Pain Scores
Time frame: Up to 4 weeks following treatment
Paired Dose Pain Score Comparison
Time frame: Up to 4 weeks following treatment
Post Treatment Measures
Time frame: Up to 12 months following treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Paul W Read, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy in people with Metastatic Bone Lesion, run by Paul W. Read, MD at 1 site in United States.
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 7 inclusion and 8 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dose (time frame: Up to 12 months following treatment). 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 12 Jun 2018.