Bone MetastasesNCT01391234
Rapid Radiation Therapy for Painful Osseous Metastatic Disease
A study testing STAT RT planning and delivery workflow in people with Bone Metastases, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of an experimental workflow that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (tumors that originally came from another organ and have spread to bones causing pain) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- STAT RT planning and delivery workflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 a biopsy proven diagnosis of cancer. The osseous metastatic lesions do not need to be biopsied.
- Patients with multiple myeloma are eligible for the study.
- Patient has 1-3 major painful osseous metastases (target lesions) from any primary cancer or unknown primary cancer.
- Long bone target lesions must have a Mirels fracture score of ≤ 7.
- Patients with spinal cord compression from vertebral body metastases are not eligible.
- Target lesions have not previously been treated with radiation.
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- Radiation oncologist determines that the patient is medically able to undergo palliative radiation therapy.
- Patient has target lesions that are radiographically consistent with metastatic disease on CT, MR, or PET CT obtained within 8 weeks of treatment.
- Persistent distinguishable pain associated with target sites to be treated.
- Patient average BPI pain score for last 72 hours at specified location is > 3 (0-10 scale)
- Patients may have additional non-painful or minimally painful osseous metastases (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the BPI compared to the site(s) treated)
- The patient may have previously been treated with radiation therapy to other body sites, but not to the target lesions.
- The patient may have previously or currently be undergoing chemotherapy or bisphosphonate therapy.
- The patient will be able understand English (or a medical interpreter for their native language must be available for all study visits).
- 18 years of age or older.
- Life expectancy > 12 weeks.
- Able and willing to answer simple survey questionnaires.
- Able and willing to keep a logbook of analgesic use (with or without assistance).
- Willing to return to clinic for follow-up visits after first treatment.
- Signed study-specific informed consent form
Who cannot join
- Inability to lie flat on table for treatment
- Patient with < 12 weeks life expectancy
- Systemic radionuclide delivery within 30 days prior to treatment
- Epidural compression of spinal cord or cauda equine
- Spinal canal compromise > 25%
- Unstable spine requiring surgical stabilization
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- Target lesions have previously been treated with radiation.
- Tumor located within 5mm of spinal cord or cauda equina.
- A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapy.
- Pregnant and breastfeeding women are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Phase II Pilot Single Arm Prospective Clinical Trial of Rapid Institution of 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 workflow that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (tumors that originally came from another organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that begins in white blood cells that produce antibodies).
The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks from start to finish. The investigators have developed an experimental workflow: a radiation treatment planning and delivery workflow called "STAT RT" (STAT means "right away", and RT means radiation therapy). This experimental workflow may shorten the time it takes to plan and treat painful bone metastases to 1 week or less. All steps in this process will be performed within the current standard of care but in a shorter time frame to allow treatment to start sooner.
The investigators will evaluate effectiveness by requesting patients to complete pain and quality of life questionnaires before and after treatment. The investigators will also be collecting additional information from their treatments that will help us make future workflows even more efficient.
Read the detailed description
Background: Osseous metastatic disease causes significant pain, decreased functioning, and decreased quality of life. Progressive bone destruction can lead to pathologic fractures or spinal cord compression leading to orthopedic surgery, paralysis, and/or patients becoming bedridden. Opioids can alleviate pain but have neurologic and gastrointestinal side effects that further decrease quality of life. Radiation therapy can effectively reduce pain and opioid use and prevent further bone destruction, however, its use is limited because the current workflow frequently requires one week for planning and two weeks for delivery. Additionally, typical palliative radiation plans for osseous metastases lack conformality of dose to the tumor volume, and therefore, result in radiation-induced toxicity to large volumes of adjacent normal tissue. Recent software and hardware advancements provide the opportunity to revolutionize the palliative treatment of osseous metastases. The investigators propose to investigate a novel TomoTherapy-based workflow, called STAT RT, which includes same day CT simulation, treatment planning, and quality assurance measurements coupled with highly conformal treatment delivery for patients with osseous metastases in a pilot clinical trial.
Objective: The overall goal of this STAT RT proposal is to develop a more rapid, convenient, and effective palliative radiation approach for patients with osseous metastases that is less toxic and less expensive than current treatment regimens. The investigators have already optimized the conformality of TomoTherapy-based radiation doses for osseous metastases, and the investigators have developed a STAT RT workflow that condenses standard of care simulation, planning, quality assurance, and treatment delivery into 5-6 hours. Additional optimization and integration of new radiation therapy computing processes will allow for real time simulation, planning, and delivery via a novel Scan-Plan-Treat STAT RT workflow that will ultimately require only 30 minutes. In this study the investigators will evaluate the effectiveness of the current STAT RT workflow, and the investigators will investigate techniques for further optimization that will be needed to create a 30 minute Scan-Plan-Treat STAT RT workflow.
Primary Specific Aim/ Hypothesis: The investigators will quantify the time for pain relief, amount of pain relief, opioid use reduction, functional scores, quality of life, and satisfaction of patients treated with STAT RT for osseous metastases. The investigators hypothesize that these patients will have rapid and significant pain relief, improved quality of life, and high patient satisfaction.
Secondary Specific Aim/ Hypothesis: The investigators will optimize the integration of commercially available and in-development software to develop the Scan-Plan-Treat STAT RT workflow. Specifically, the investigators will A) optimize rigid and deformable co-registration of pre-contoured diagnostic image sets to MVCT simulation scans and compare the accuracy to the same pre-contoured diagnostic image sets co-registered to kilovoltage CT (kVCT) simulation images and then kVCT simulation to MVCT scan co-registration, B) optimize CT-detector-based exit dose measurement algorithms for quality assurance and compare to standard of care phantom-based quality assurance, C) optimize the accuracy of an in-house real time infrared tracking system for intrafractional patient position monitoring to ensure accurate patient treatment. The investigators hypothesize that these new components will provide effective and efficient methods for treatment planning, quality assurance, and patient position monitoring that can be used in a future 30 minute Scan-Plan-Treat STAT RT workflow.
Study design: The investigators will recruit 30 cancer patients with 1-3 painful osseous metastatic lesions (target sites) who are candidates for palliative radiation therapy. Patients will receive 1-5 fractions of 5-8 Gray (Gy) (minimum biologic effective dose of 25 Gy) of conformal radiation therapy delivered to the target sites via the Helical TomoTherapy system using the STAT RT workflow. Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques. Using validated surveys the investigators will record patient pain, analgesic use, function, quality of life, and patient satisfaction prior to treatment and at 1 week, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after therapy. Radiation-induced treatment related toxicities will be captured during treatment and at the above time points.
- Conditions
- Bone Metastases
- Being tested
- STAT RT planning and delivery workflow
- Keywords
- Metastatic bone disease, Bone metastases, Radiation therapy, TomoTherapy
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT RT planning and delivery workflowRadiation
Also called TomoTherapy-based Radiation Therapy
- Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow.
- Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction.
- Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
| Study group | Role | What they receive |
|---|---|---|
| STAT RT planning and delivery workflow | Experimental | single arm Receives: Radiation: STAT RT planning and delivery workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months
The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), Stable Pain (no change in pain), and Pain Progression at 12 months after receiving treatment via the STAT RT workflow.
Measured: 12 months after treatment
Secondary outcomes (25)
Number of Participants With Treatment Toxicity
Toxicity will be assessed by CTCAE Version 4.0 Toxicity will be assessed up to 12 months after treatment.
Measured: 12 months after treatment
Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment
The patient's quality of life function will be assessed using the Brief Pain Inventory (BPI) 1 week post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 1 Week Post Treatment
Number of Participants With an Improved Quality of Life Function Score at 4 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 4 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 4 weeks post treatment
Number of Participants With an Improved Quality of Life Function Score at 8 Weeks After Initial Treatment
The patient's quality of life function will be assessed using the Brief Pain Inventory (BPI) 8 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 8 weeks post initial treatment
Number of Participants With an Improved Quality of Life Function Score at 12 Weeks Post Initial Treatment
The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 12 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 12 weeks post treatment.
Number of Participants With an Improved Quality of Life Function Score at 6 Months After Initial Treatment
the patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 6 months post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 6 months post treatment
Number of Participants With an Improved Quality of Life Function Score at 12 Months After Initial Treatment
The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 12 months post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.
Measured: 12 months post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 1 Week Post Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 1 week post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 1 week post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 4 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 4 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 4 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 8 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 8 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 8 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 12 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 12 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 12 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 6 Months After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 6 months post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 6 months post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 12 Months After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 12 months post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.
Measured: 12 months post treatment
Patient Quality of Life and Function (FACT-G) Assessed 1 Week After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 1 week post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 1 week post treatment
Patient Quality of Life and Function (FACT-G) Assessed 4 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 4 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 4 weeks post treatment
Patient Quality of Life and Function (FACT-G) Assessed 8 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 8 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 8 weeks post treatment
Patient Quality of Life and Function (FACT-G) Assessed 12 Weeks After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 12 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 12 weeks post treatment.
Patient Quality of Life and Function (FACT-G) Assessed 6 Months After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 6 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 6 months post treatment
Patient Quality of Life and Function (FACT-G) Assessed 12 Months After Initial Treatment
The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 12 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).
Measured: 12 months post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 1 Week After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 1 week post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 1 week post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 4 Weeks After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 4 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 4 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 8 Weeks After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 8 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 8 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Weeks After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 12 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 12 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 6 Months After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 6 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 6 months post treatment.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Months After Initial Treatment
Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 12 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul W. Read, MD, University of Virginia
- Investigators
- Paul W Read, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391234
- Sponsor's protocol ID
- 15625
- Status last verified
- Nov 2022
- First submitted
- 14 Jun 2011
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Single Arm Prospective Clinical Trial of Rapid Institution of Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease
- ClinicalTrials.gov ID
- NCT01391234
- Acronym / sponsor ID
- 15625
- Conditions
- Bone Metastases
- Keywords
- Metastatic bone disease, Bone metastases, Radiation therapy, TomoTherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 1 Dec 2022
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 workflow that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (tumors that originally came from another organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that begins in white blood cells that produce antibodies).
The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks from start to finish. The investigators have developed an experimental workflow: a radiation treatment planning and delivery workflow called "STAT RT" (STAT means "right away", and RT means radiation therapy). This experimental workflow may shorten the time it takes to plan and treat painful bone metastases to 1 week or less. All steps in this process will be performed within the current standard of care but in a shorter time frame to allow treatment to start sooner.
The investigators will evaluate effectiveness by requesting patients to complete pain and quality of life questionnaires before and after treatment. The investigators will also be collecting additional information from their treatments that will help us make future workflows even more efficient.
Detailed description
Background: Osseous metastatic disease causes significant pain, decreased functioning, and decreased quality of life. Progressive bone destruction can lead to pathologic fractures or spinal cord compression leading to orthopedic surgery, paralysis, and/or patients becoming bedridden. Opioids can alleviate pain but have neurologic and gastrointestinal side effects that further decrease quality of life. Radiation therapy can effectively reduce pain and opioid use and prevent further bone destruction, however, its use is limited because the current workflow frequently requires one week for planning and two weeks for delivery. Additionally, typical palliative radiation plans for osseous metastases lack conformality of dose to the tumor volume, and therefore, result in radiation-induced toxicity to large volumes of adjacent normal tissue. Recent software and hardware advancements provide the opportunity to revolutionize the palliative treatment of osseous metastases. The investigators propose to investigate a novel TomoTherapy-based workflow, called STAT RT, which includes same day CT simulation, treatment planning, and quality assurance measurements coupled with highly conformal treatment delivery for patients with osseous metastases in a pilot clinical trial.
Objective: The overall goal of this STAT RT proposal is to develop a more rapid, convenient, and effective palliative radiation approach for patients with osseous metastases that is less toxic and less expensive than current treatment regimens. The investigators have already optimized the conformality of TomoTherapy-based radiation doses for osseous metastases, and the investigators have developed a STAT RT workflow that condenses standard of care simulation, planning, quality assurance, and treatment delivery into 5-6 hours. Additional optimization and integration of new radiation therapy computing processes will allow for real time simulation, planning, and delivery via a novel Scan-Plan-Treat STAT RT workflow that will ultimately require only 30 minutes. In this study the investigators will evaluate the effectiveness of the current STAT RT workflow, and the investigators will investigate techniques for further optimization that will be needed to create a 30 minute Scan-Plan-Treat STAT RT workflow.
Primary Specific Aim/ Hypothesis: The investigators will quantify the time for pain relief, amount of pain relief, opioid use reduction, functional scores, quality of life, and satisfaction of patients treated with STAT RT for osseous metastases. The investigators hypothesize that these patients will have rapid and significant pain relief, improved quality of life, and high patient satisfaction.
Secondary Specific Aim/ Hypothesis: The investigators will optimize the integration of commercially available and in-development software to develop the Scan-Plan-Treat STAT RT workflow. Specifically, the investigators will A) optimize rigid and deformable co-registration of pre-contoured diagnostic image sets to MVCT simulation scans and compare the accuracy to the same pre-contoured diagnostic image sets co-registered to kilovoltage CT (kVCT) simulation images and then kVCT simulation to MVCT scan co-registration, B) optimize CT-detector-based exit dose measurement algorithms for quality assurance and compare to standard of care phantom-based quality assurance, C) optimize the accuracy of an in-house real time infrared tracking system for intrafractional patient position monitoring to ensure accurate patient treatment. The investigators hypothesize that these new components will provide effective and efficient methods for treatment planning, quality assurance, and patient position monitoring that can be used in a future 30 minute Scan-Plan-Treat STAT RT workflow.
Study design: The investigators will recruit 30 cancer patients with 1-3 painful osseous metastatic lesions (target sites) who are candidates for palliative radiation therapy. Patients will receive 1-5 fractions of 5-8 Gray (Gy) (minimum biologic effective dose of 25 Gy) of conformal radiation therapy delivered to the target sites via the Helical TomoTherapy system using the STAT RT workflow. Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques. Using validated surveys the investigators will record patient pain, analgesic use, function, quality of life, and patient satisfaction prior to treatment and at 1 week, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after therapy. Radiation-induced treatment related toxicities will be captured during treatment and at the above time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAT RT planning and delivery workflow | Experimental | Radiation: STAT RT planning and delivery workflowsingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient has a biopsy proven diagnosis of cancer. The osseous metastatic lesions do not need to be biopsied.
- Patients with multiple myeloma are eligible for the study.
- Patient has 1-3 major painful osseous metastases (target lesions) from any primary cancer or unknown primary cancer.
- Long bone target lesions must have a Mirels fracture score of ≤ 7.
- Patients with spinal cord compression from vertebral body metastases are not eligible.
Key exclusion criteria (10 listed)
- Inability to lie flat on table for treatment
- Patient with < 12 weeks life expectancy
- Systemic radionuclide delivery within 30 days prior to treatment
- Epidural compression of spinal cord or cauda equine
- Spinal canal compromise > 25%
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 |
|---|---|---|
| STAT RT planning and delivery workflowAlso: TomoTherapy-based Radiation Therapy* Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques. | Radiation | STAT RT planning and delivery workflow |
Primary outcome
Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months
Time frame: 12 months after treatment
The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), Stable Pain (no change in pain), and Pain Progression at 12 months after receiving treatment via the STAT RT workflow.
25 secondary outcomes
Number of Participants With Treatment Toxicity
Time frame: 12 months after treatment
Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment
Time frame: 1 Week Post Treatment
Number of Participants With an Improved Quality of Life Function Score at 4 Weeks After Initial Treatment
Time frame: 4 weeks post treatment
Number of Participants With an Improved Quality of Life Function Score at 8 Weeks After Initial Treatment
Time frame: 8 weeks post initial treatment
Number of Participants With an Improved Quality of Life Function Score at 12 Weeks Post Initial Treatment
Time frame: 12 weeks post treatment.
Number of Participants With an Improved Quality of Life Function Score at 6 Months After Initial Treatment
Time frame: 6 months post treatment
Number of Participants With an Improved Quality of Life Function Score at 12 Months After Initial Treatment
Time frame: 12 months post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 1 Week Post Initial Treatment
Time frame: 1 week post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 4 Weeks After Initial Treatment
Time frame: 4 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 8 Weeks After Initial Treatment
Time frame: 8 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 12 Weeks After Initial Treatment
Time frame: 12 weeks post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 6 Months After Initial Treatment
Time frame: 6 months post treatment
Patient Quality of Life and Function (FACT-BP) Assessed 12 Months After Initial Treatment
Time frame: 12 months post treatment
Patient Quality of Life and Function (FACT-G) Assessed 1 Week After Initial Treatment
Time frame: 1 week post treatment
Patient Quality of Life and Function (FACT-G) Assessed 4 Weeks After Initial Treatment
Time frame: 4 weeks post treatment
Patient Quality of Life and Function (FACT-G) Assessed 8 Weeks After Initial Treatment
Time frame: 8 weeks post treatment
Patient Quality of Life and Function (FACT-G) Assessed 12 Weeks After Initial Treatment
Time frame: 12 weeks post treatment.
Patient Quality of Life and Function (FACT-G) Assessed 6 Months After Initial Treatment
Time frame: 6 months post treatment
Patient Quality of Life and Function (FACT-G) Assessed 12 Months After Initial Treatment
Time frame: 12 months post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 1 Week After Initial Treatment
Time frame: 1 week post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 4 Weeks After Initial Treatment
Time frame: 4 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 8 Weeks After Initial Treatment
Time frame: 8 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Weeks After Initial Treatment
Time frame: 12 weeks post treatment
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 6 Months After Initial Treatment
Time frame: 6 months post treatment.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Months After Initial Treatment
Time frame: 12 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 study chair
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 STAT RT planning and delivery workflow in people with Bone Metastases, run by University of Virginia 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 20 inclusion and 10 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: finished, as of the sponsor's last update on 1 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months (time frame: 12 months after 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 1 Dec 2022.