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low participant accrual
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The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy to Local Spine Metastasis | Experimental | Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conformal High Dose Intensity Modulated Radiation Therapy | Radiation | Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Any Skeletal Related Event | Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival). | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Radiation Toxicity | The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy) | 90 days |
| Late Radiation Toxicity | The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald McGarry, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy to Local Spine Metastasis | Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy to Local Spine Metastasis | Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Any Skeletal Related Event | Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival). | Posted | Median | Full Range | weeks | up to 24 months |
|
|
0-209 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Therapy to Local Spine Metastasis | Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertebral Compression Fractures | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilateral Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronal McGarry | University of Kentucky | 859-323-6486 | rcmcga2@email.uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2013 | Mar 19, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2013 | Mar 19, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008968 | Molecular Conformation |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D020266 | Radiotherapy, Conformal |
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| 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Site of Metastasis | Count of Participants | Participants |
|
|
|
| Secondary | Acute Radiation Toxicity | The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy) | Posted | Number | event (possible acute side effect) | 90 days |
|
|
|
| Secondary | Late Radiation Toxicity | The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy) | Posted | Number | events (possible late side effects) | 2 years |
|
|
|
| 11 |
| 14 |
| 2 |
| 14 |
| 1 |
| 14 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D011881 |
| Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |