N/A
N=28
Rapid Radiation Therapy for Painful Osseous Metastatic Disease
Bone Metastases
Bottom Line
View on ClinicalTrials.gov: NCT01391234 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STAT RT planning and delivery workflow (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months |
9 | — |
| SECONDARY Number of Participants With Treatment Toxicity |
— | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment |
19 | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 4 Weeks After Initial Treatment |
21 | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 8 Weeks After Initial Treatment |
15 | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 12 Weeks Post Initial Treatment |
15 | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 6 Months After Initial Treatment |
13 | — |
| SECONDARY Number of Participants With an Improved Quality of Life Function Score at 12 Months After Initial Treatment |
10 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 1 Week Post Initial Treatment |
19 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 4 Weeks After Initial Treatment |
21 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 8 Weeks After Initial Treatment |
15 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 12 Weeks After Initial Treatment |
15 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 6 Months After Initial Treatment |
13 | — |
| SECONDARY Patient Quality of Life and Function (FACT-BP) Assessed 12 Months After Initial Treatment |
10 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 1 Week After Initial Treatment |
19 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 4 Weeks After Initial Treatment |
21 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 8 Weeks After Initial Treatment |
15 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 12 Weeks After Initial Treatment |
15 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 6 Months After Initial Treatment |
13 | — |
| SECONDARY Patient Quality of Life and Function (FACT-G) Assessed 12 Months After Initial Treatment |
10 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 1 Week After Initial Treatment |
19 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 4 Weeks After Initial Treatment |
21 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 8 Weeks After Initial Treatment |
14 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Weeks After Initial Treatment |
13 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 6 Months After Initial Treatment |
13 | — |
| SECONDARY Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Months After Initial Treatment |
9 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
Exclusion Criteria
- Inability to lie flat on table for treatment
- Patient with 25%
- Unstable spine requiring surgical stabilization
- 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.
Data sourced from ClinicalTrials.gov (NCT01391234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.