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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.
All supportive therapy for optimal medical care will be given during the study period at the discretion of the attending physician(s) within the parameters of the protocol and documented on each site's source documents as concomitant medication.
The study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
Patients will be stratified according to the tumor type (radioresistant [soft tissue sarcoma, melanoma, and renal cell carcinoma] versus other types). The treatment allocation scheme described by Zelen (1974) will be used because it balances patient factors. Within each stratum, patients will be randomized in a 2:1 ratio to either image-guided RT plus RFA/PVA or external beam RT alone.
The 2:1 randomization allocation will be used to accommodate increased demand for image-guided RT plus RFA/PVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Other | Radiotherapy alone |
|
| Radiotherapy plus radiofrequency ablation | Other | Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 30 Gy in 10 fractions of 3 Gy each |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain control | Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone. | 3 months, 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain response | Change in the rapidity of pain response at the treated site(s) as compared to conventional Radiotherapy alone, as measured by the Numeric pain rating scale. | 3 months, 6, 12, 24 months |
| Measure increases in the duration of pain response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rupesh Kotecha, MD | Miami Cancer Institute (MCI) at Baptist Health South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health South Florida | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228756 | Derived | Kotecha R, Schiro BJ, Sporrer J, Rubens M, Appel HR, Calienes KS, Boulanger B, Pujol MV, Suarez DT, Pena A, Kudryashev A, Mehta MP. Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials. 2020 Nov 23;21(1):964. doi: 10.1186/s13063-020-04895-x. |
| Label | URL |
|---|---|
| Miami Cancer Institute website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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A study design of 2:1 randomization scheme (RT plus PVA/RFA:RT), the study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
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| Radiofrequency Ablation (RFA) | Radiation | Radiofrequency Ablation (RFA) / Vertebral Augmentation |
|
Measure increases in the duration of pain response at the treated site(s), as compared to conventional RT alone, as measured by the Numeric pain rating scale. |
| 3 months, 6, 12, 24 months |
| Number of adverse events | Number of adverse events between the two treatments according to the NCI Common Terminology Criteria for Adverse Events version 5.0. | 3 months, 6, 12, 24 months |
| Measure the potential benefit on quality of life | Measure the potential benefit of radiotherapy plus Vertebral Augmentation/Radiofrequency Ablation on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General; in pain as measured by the Brief Pain Inventory; and in health utilities as measured by the EuroQol | 3 months, 6, 12, 24 months |