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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01222 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 007683 | |||
| 2015-4957 | Other Identifier | Albert Einstein College of Medicine | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT uses information gathered during treatment to inform, guide, and alter future radiation treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.
PRIMARY OBJECTIVES:
I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment.
SECONDARY OBJECTIVES:
I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment.
II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment.
III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment.
OUTLINE:
Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (adaptive staged SBRT) | Experimental | Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-Guided Adaptive Radiation Therapy | Radiation | Undergo adaptive staged SBRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. | Cord-disease distance of at least 3mm in shortest axial distance after treatment. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion were computed using Clopper-Pearson exact confidence interval were not conducted. Since this was a feasibility, study no power calculation was done. | Up to 10 weeks after first treatment |
| Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor | Successful radiographic response of the spinal tumor was determined by achieving of a 10% reduction in epidural volume or thecal sac compression (i.e., ~10% absolute increase in thecal sac patency (TSP)) following treatment, on either of their MRI imaging or CT myelogram scans. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion using Clopper-Pearson exact confidence interval were not conducted. Since this is a feasibility study no power calculation was done. | Up to 10 weeks after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ambulation (Mobility) | Ambulation was assessed as a functional outcome by the treating physician. Scoring was adapted from the ICORG Phase III trial, ASTRO 2014. Mobility scores were assigned as follows: 1 = ambulatory without aid; 2 = ambulatory with aid; 3 = not ambulatory; and 4 = paraplegia. Basic descriptive statistics were used to assess changes in ambulation from baseline. | 10 weeks after first treatment |
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Inclusion Criteria:
Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging [MRI] or computed tomography [CT] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
History/physical examination by the treating physician within 24 hours prior to registration
Neurological and functional examination within 24 hours prior to registration by the treating physician
Negative serum pregnancy test
MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
Women of childbearing potential must:
All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhur Garg | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Adaptive Staged SBRT) | Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 15, 2016 |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Stereotactic Body Radiation Therapy | Radiation | Undergo adaptive staged SBRT |
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| Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation | Participants were asked to provide a numeric value using the NPRS to describe their pain intensity. The NPRS is a unidimensional assessment tool which measures pain on an 11-point (0-10) numeric scale where "0" represents no pain and "10" represents extreme pain. Higher scores are indicative of worsening pain intensity. | Up to 10 weeks after first treatment |
| Health Related Quality of Life Scores (FACT-G) | Health-related Quality of Life was measured using Functional Assessment of Cancer Therapy - General (FACT-G) a 27-item questionnaire designed to measure four domains of Quality of Life in cancer patients assessed over the previous 7-day period: physical well-being (7 questions), social/family well-being (7 questions), emotional being (6 questions), and functional well-being (7 questions). Participant responses are assessed using a 5 point Likert-type scale ranging from 0 (Not at all) to 4 (Very much). A FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e. at least 22 of the 27 items answered) and has a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate a better overall health state corresponding Quality of Life. | Up to 3 months following first treatment |
| Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4 | Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity | Up to 2 years |
| Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4 | Data will be reported in a descriptive manner to describe any incidence of grade 2 or greater related radiation induced lung toxicity | Up to 2 years |
| Overall Survival | Data will be reported in a descriptive manner. | From study registration to death, censored at the date of data collection, assessed up to 2 years |
| Progression-free Survival | Data will be reported in a descriptive manner. | From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years |
| COMPLETED |
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| NOT COMPLETED |
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total patients enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Adaptive Staged SBRT) | Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Numeric Pain Rating Scale | The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 0 indicates "no pain", and 10 indicates "worst possible pain." | Mean | Standard Deviation | units on a scale |
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| 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 | Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. | Cord-disease distance of at least 3mm in shortest axial distance after treatment. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion were computed using Clopper-Pearson exact confidence interval were not conducted. Since this was a feasibility, study no power calculation was done. | Data was not collected and analyzed for 9 participants due to no post-treatment imaging being obtained. Imaging was unable to be conducted for these participants due to either a decline in subjects' clinical status or death. Confidence intervals were not determined given data limitations and had no impact due to feasibility design of study. | Posted | Count of Participants | Participants | Up to 10 weeks after first treatment |
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| Primary | Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor | Successful radiographic response of the spinal tumor was determined by achieving of a 10% reduction in epidural volume or thecal sac compression (i.e., ~10% absolute increase in thecal sac patency (TSP)) following treatment, on either of their MRI imaging or CT myelogram scans. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion using Clopper-Pearson exact confidence interval were not conducted. Since this is a feasibility study no power calculation was done. | Data was not collected and analyzed for 10 participants due to no post-treatment MRI or CT myelograms being obtained. Imaging was unable to be conducted for these 10 participants due to either a decline in subjects' clinical status or death. Confidence intervals were not determined given data limitations and had no impact due to feasibility design of study. | Posted | Count of Participants | Participants | Up to 10 weeks after first treatment |
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| Secondary | Change in Ambulation (Mobility) | Ambulation was assessed as a functional outcome by the treating physician. Scoring was adapted from the ICORG Phase III trial, ASTRO 2014. Mobility scores were assigned as follows: 1 = ambulatory without aid; 2 = ambulatory with aid; 3 = not ambulatory; and 4 = paraplegia. Basic descriptive statistics were used to assess changes in ambulation from baseline. | Posted | Mean | Standard Deviation | Change in ambulation measure score | 10 weeks after first treatment |
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| Secondary | Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation | Participants were asked to provide a numeric value using the NPRS to describe their pain intensity. The NPRS is a unidimensional assessment tool which measures pain on an 11-point (0-10) numeric scale where "0" represents no pain and "10" represents extreme pain. Higher scores are indicative of worsening pain intensity. | Data was not collected and analyzed for all patient due to diminishing clinical status or death. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks after first treatment |
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| Secondary | Health Related Quality of Life Scores (FACT-G) | Health-related Quality of Life was measured using Functional Assessment of Cancer Therapy - General (FACT-G) a 27-item questionnaire designed to measure four domains of Quality of Life in cancer patients assessed over the previous 7-day period: physical well-being (7 questions), social/family well-being (7 questions), emotional being (6 questions), and functional well-being (7 questions). Participant responses are assessed using a 5 point Likert-type scale ranging from 0 (Not at all) to 4 (Very much). A FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e. at least 22 of the 27 items answered) and has a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate a better overall health state corresponding Quality of Life. | Data was not collected and analyzed for 15 participants due to either a decline in subjects' clinical status or death. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 months following first treatment |
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| Secondary | Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4 | Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4 | Data will be reported in a descriptive manner to describe any incidence of grade 2 or greater related radiation induced lung toxicity | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Overall Survival | Data will be reported in a descriptive manner. | patients | Posted | Count of Participants | Participants | From study registration to death, censored at the date of data collection, assessed up to 2 years |
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| Secondary | Progression-free Survival | Data will be reported in a descriptive manner. | Posted | Count of Participants | Participants | From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years |
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Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
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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 | Treatment (Adaptive Staged SBRT) | Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT | 0 | 24 | 0 | 24 | 5 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary Frequency (Increased) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 1. Related to Sunitinib |
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| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3. Related to Afatinib treatment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3. Related to Afatinib treatment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
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| Conjuctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Paronychia | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Weight Loss | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Rash (nonspecific) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
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| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Madhur Garg, Clinical Director, Department of Radiation Oncology | Montefiore Medical Center | 718-920-4361 | mgarg@montefiore.org |
| Jan 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| D012509 | Sarcoma |
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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