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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00906 | Registry Identifier | NCI Clinical Trial Registration Program |
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The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence.
Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
Stratification for treatment will be determined when radiation therapy planning is initiated. Patients will be stratified for outcome according to diagnosis and prior therapy.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
Other Pre-Specified (Exploratory) Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1: Local Failure | Experimental | Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy. Participants may receive one or both: Photon therapy or proton therapy. Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization. |
|
| Stratum 2: Metastatic Failure | Experimental | Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume. Participants may receive one or both: Photon therapy or proton therapy. Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization. |
|
| Stratum 3: Local and Metastatic Failure | Experimental | Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Participants may receive one or both: Photon therapy or proton therapy. Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irradiation | Radiation | Radiation therapy on this protocol will be based on extent of disease, extent of resection and location. The allowed treatment modalities include conformal or intensity-modulated radiation therapy using photons or proton therapy using double-scattering or spot-scanning methods. The general goal is to initiate radiation therapy within 12 weeks of last surgery performed at the time of recurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Progression-free Survival Rate | To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation. | 2 years follow-up after initiation of radiation therapy for the last patient enrolled |
| 3-year Overall Survival Rate | OS was calculated from the date of initial radiation therapy to date of death or date of last contact for the patients who were treated with RT. The event of interest was death. | 2 years follow-up after initiation of radiation therapy for the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Neurological Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcomes will be reported by p-values. | Through 5 years after initiation of second course of irradiation |
| Incidence Rate of Ophthalmological Deficits |
| Measure | Description | Time Frame |
|---|---|---|
| Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy | Baseline is the last FDG-PET and MET-PET prior to initiation of radiation therapy. | Baseline |
| Longitudinal Change of Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Merchant, DO, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Of 70 enrollments, 3 were found to be ineligible and removed; 3 withdrew before reirradiation to seek other treatment. One participant who was initially ineligible was later found to be eligible and re-enrolled, and a participant who had previously withdrawn to seek other treatment options decided to pursue reirradiation and re-enrolled. The 2 screen failures St. Jude pathology did not result ependymoma diagnosis after consent as expected. Sixty-four (64) completed reirradiation treatment.
70 enrollments occurred on 68 participants between from April 21, 2014 and June 30, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reirradiation | Children and young adults with Recurrent Ependymoma undergoing reirradiation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children and young adults with Recurrent Ependymoma undergoing reirradiation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reirradiation | Children and young adults with Recurrent Ependymoma undergoing reirradiation. |
| 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 | 3-year Progression-free Survival Rate | To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years follow-up after initiation of radiation therapy for the last patient enrolled |
|
|
11C-Methionine-Related Adverse Events: From time of injection through one hour post injection of 11C-methionine. Radiation-Related Adverse Events: From initiation of radiation therapy through study completion, an average of 2 years.
All-cause mortality was assessed in eligible participants who received radiation therapy. Adverse events were assessed in eligible participants with adverse event data who received radiation therapy.
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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 | Reirradiation | Children and young adults with Recurrent Ependymoma undergoing reirradiation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Unrelated to radiation therapy, resulted in patient's death. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas E. Merchant, DO, PhD | St. Jude Children's Research Hospital | 8662785833 | referralinfo@stjude.org |
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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 | Feb 1, 2023 | Aug 21, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | Aug 21, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D061888 | Craniospinal Irradiation |
| D013514 | Surgical Procedures, Operative |
| D059146 | Metastasectomy |
| D019788 | Fluorodeoxyglucose F18 |
| D003287 | Contrast Media |
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D003847 | Deoxyglucose |
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|
| Stratum 4: Local Failure | Experimental | Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation. Participants may receive one or both: Photon therapy or proton therapy. Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization. |
|
|
|
| Surgery | Procedure | When applicable, surgery will be used to remove metastases. The goal of surgery is to achieve gross total resection of all imaging visible residual tumor. |
|
|
| ^1^8F-Fluorodeoxyglucose | Drug | This is a contrast media that will be given intravenously to aid in tumor visualization. |
|
|
| ^1^1C-methionine | Drug | This is a contrast media that will be given intravenously to aid in tumor visualization. |
|
|
| Photon therapy | Device | Participants will receive one or both: Photon or proton therapy. |
|
|
| Proton therapy | Device | Participants will receive one or both: Photon or proton therapy. |
|
|
Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p values. |
| Through 5 years after initiation of second course of irradiation |
| Incidence Rate of Audiological Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values. | Through 5 years after initiation of second course of irradiation |
| Incidence Rate of Endocrine Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values. | Through 5 years after initiation of second course of irradiation |
| Number of Neurocognitive Deficits | Through 5 years after initiation of second course of irradiation |
| Mean Change in Quality of Life by Treatment Arm | Baseline is defined as day 1 of radiation therapy. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Measured Task Sets | Baseline is defined as day 1 of radiation therapy. Measured task sets: BOT2 (4-21 years old) and PPT (≥22 years old).
The above scores will be standardized into z-scores/T-scores for data analysis based on normative data. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Physical Function | Baseline is defined as day 1 of radiation therapy. Self-reported instruments (PROMIS): Three questionnaires.
The above scores will be standardized into z-scores/T-scores for data analysis based on normative data | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Body Mass Index (kg/m2) | Baseline is defined as day 1 of radiation therapy | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Waist/Hip Ratio (cm/cm) | Baseline is defined as day 1 of radiation therapy. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Ankle Dorsiflexion | Baseline is defined as day 1 of radiation therapy. Ankle dorsiflexion active and passive range of motion: measured by goniometer, and recorded as an angle (degree). | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Overall Flexibility in cm | Baseline is defined as day 1 of radiation therapy. Overall flexibility: measured by sit and reach test, and recorded as a length (cm). | Baseline through 5 years after initiation of radiation therapy |
| Proportion Change in Balance | Baseline is defined as day 1 of radiation therapy. Balance measured by Measured by sensory organization test (SOT), and the result from the test is the equilibrium score, a percentage range from 0% to 100%, with the higher percentage, the better balance. The outcome is a binary variable with a cutoff score of < 70% indicates future risk for a fall. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Fine Motor Coordination | Baseline is defined as day 1 of radiation therapy. Fine motor coordination (finger and hand coordination). Measured by Composite Cerebellar Functional Severity Score (CCFS), and the outcome is an age-adjusted z-score and log transformed. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Overall Coordination | Baseline is defined as day 1 of radiation therapy. Overall coordination measured by brief ataxia rating scale (five-item questionnaire). The outcome is a total scale range from 0 to 22. | Fine motor coordination (finger and hand coordination). |
| Mean Change of Lower Extremity Strength and Power | Baseline is defined as day 1 of radiation therapy. Lower extremity strength measured by BiodexIII. The outcomes are peak torque value/body weight ratios at different speeds of motion. The scores will be standardized into z-scores for data analysis based on normative data. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Hand Grip Strength | Baseline is defined as day 1 of radiation therapy. Hand grip strength is measured by a Jamar hand held dynamometer and recorded in kilograms (kg). The scores will be standardized into z-scores for data analysis based on normative data. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Resting Energy Expenditure | Baseline is defined as day 1 of radiation therapy. Resting energy expenditure is measured with indirect calorimetry after an overnight fast and recorded as REE (kcal/day). The scores will be standardized into z-scores for data analysis based on normative data. | Baseline through 5 years after initiation of radiation therapy |
| Mean Change in Cardiopulmonary Exercise Test (CPET) | Baseline is defined as day 1 of radiation therapy. Cardiopulmonary exercise test (CPET) will be completed on a treadmill using the Balke protocol or cycle ergometer using an incremental ramping protocol. The outcome is recorded as VO2max (ml/kg/min). The scores will be standardized into z-scores for data analysis based on normative data. | Baseline through 5 years after initiation of radiation therapy |
| Longitudinal Change of Size (or Extent if Leptomeningeal Dissemination) of Residual Tumor | Baseline is defined as the last MRI prior to initiation of radiation therapy. | Baseline through 5 years after initiation of radiation therapy |
| Longitudinal Change of Incidence and Severity of Structural Effects of Normal Brain | Baseline is defined as the last MRI prior to initiation of radiation therapy. | Baseline through 5 years after initiation of radiation therapy |
| Longitudinal Change in Gray and White Matter Tissues | This outcome will be evaluated by neuroimaging. Baseline is defined as day 1 of radiation therapy. | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years |
| Longitudinal Change of Individual Variation and Risk Factors in Gray and White Matter Tissues | Baseline is defined as day 1 of radiation therapy. | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years |
| Change Over Time in Imaging Metrics | Baseline is defined as day 1 of radiation therapy. | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years |
Correlation of avidity of ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET prior to radiation therapy with progression-free survival will be reported |
| 12, 24 and 36 months after second course of irradiation |
| Longitudinal Change of Necrosis Measured With MET/FDG and Necrosis Measured With MRI | Association between necrosis measured with MET/FDG vs. MRI Baseline is defined as day 1 of radiation therapy (RT). | Baseline, and at 12, 24 and 36 month |
| Mean Change Over Time in Cytokine Levels | Baseline is defined as day 1 of radiation therapy. | Baseline through 5 years after radiation therapy |
| Genetic Variations in Germline | Evaluate will be of genetic variations in germline associated with treatment response and side effects. P-values will be reported. Baseline is defined as day 1 of radiation therapy. | Baseline |
| 3-year Progression-free Survival (PFS) Rates by Chemotherapy Groups | 2 years after initiation of irradiation for the last patient enrolled |
| 3 Year Overall Survival (OS) Rates by Chemotherapy Groups | 2 years after initiation of irradiation for the last patient enrolled |
| Progressive Disease |
|
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Treatment Stratum | Count of Participants | Participants |
|
|
| Primary | 3-year Overall Survival Rate | OS was calculated from the date of initial radiation therapy to date of death or date of last contact for the patients who were treated with RT. The event of interest was death. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years follow-up after initiation of radiation therapy for the last patient enrolled |
|
|
|
| Secondary | Incidence Rate of Neurological Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcomes will be reported by p-values. | Not Posted | Through 5 years after initiation of second course of irradiation | Participants |
| Secondary | Incidence Rate of Ophthalmological Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p values. | Not Posted | Through 5 years after initiation of second course of irradiation | Participants |
| Secondary | Incidence Rate of Audiological Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values. | Not Posted | Through 5 years after initiation of second course of irradiation | Participants |
| Secondary | Incidence Rate of Endocrine Deficits | Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values. | Not Posted | Through 5 years after initiation of second course of irradiation | Participants |
| Secondary | Number of Neurocognitive Deficits | Not Posted | Through 5 years after initiation of second course of irradiation | Participants |
| Secondary | Mean Change in Quality of Life by Treatment Arm | Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Measured Task Sets | Baseline is defined as day 1 of radiation therapy. Measured task sets: BOT2 (4-21 years old) and PPT (≥22 years old).
The above scores will be standardized into z-scores/T-scores for data analysis based on normative data. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Physical Function | Baseline is defined as day 1 of radiation therapy. Self-reported instruments (PROMIS): Three questionnaires.
The above scores will be standardized into z-scores/T-scores for data analysis based on normative data | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Body Mass Index (kg/m2) | Baseline is defined as day 1 of radiation therapy | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Waist/Hip Ratio (cm/cm) | Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Ankle Dorsiflexion | Baseline is defined as day 1 of radiation therapy. Ankle dorsiflexion active and passive range of motion: measured by goniometer, and recorded as an angle (degree). | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Overall Flexibility in cm | Baseline is defined as day 1 of radiation therapy. Overall flexibility: measured by sit and reach test, and recorded as a length (cm). | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Proportion Change in Balance | Baseline is defined as day 1 of radiation therapy. Balance measured by Measured by sensory organization test (SOT), and the result from the test is the equilibrium score, a percentage range from 0% to 100%, with the higher percentage, the better balance. The outcome is a binary variable with a cutoff score of < 70% indicates future risk for a fall. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Fine Motor Coordination | Baseline is defined as day 1 of radiation therapy. Fine motor coordination (finger and hand coordination). Measured by Composite Cerebellar Functional Severity Score (CCFS), and the outcome is an age-adjusted z-score and log transformed. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Overall Coordination | Baseline is defined as day 1 of radiation therapy. Overall coordination measured by brief ataxia rating scale (five-item questionnaire). The outcome is a total scale range from 0 to 22. | Not Posted | Fine motor coordination (finger and hand coordination). | Participants |
| Secondary | Mean Change of Lower Extremity Strength and Power | Baseline is defined as day 1 of radiation therapy. Lower extremity strength measured by BiodexIII. The outcomes are peak torque value/body weight ratios at different speeds of motion. The scores will be standardized into z-scores for data analysis based on normative data. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Hand Grip Strength | Baseline is defined as day 1 of radiation therapy. Hand grip strength is measured by a Jamar hand held dynamometer and recorded in kilograms (kg). The scores will be standardized into z-scores for data analysis based on normative data. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Resting Energy Expenditure | Baseline is defined as day 1 of radiation therapy. Resting energy expenditure is measured with indirect calorimetry after an overnight fast and recorded as REE (kcal/day). The scores will be standardized into z-scores for data analysis based on normative data. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Mean Change in Cardiopulmonary Exercise Test (CPET) | Baseline is defined as day 1 of radiation therapy. Cardiopulmonary exercise test (CPET) will be completed on a treadmill using the Balke protocol or cycle ergometer using an incremental ramping protocol. The outcome is recorded as VO2max (ml/kg/min). The scores will be standardized into z-scores for data analysis based on normative data. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Longitudinal Change of Size (or Extent if Leptomeningeal Dissemination) of Residual Tumor | Baseline is defined as the last MRI prior to initiation of radiation therapy. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Longitudinal Change of Incidence and Severity of Structural Effects of Normal Brain | Baseline is defined as the last MRI prior to initiation of radiation therapy. | Not Posted | Baseline through 5 years after initiation of radiation therapy | Participants |
| Secondary | Longitudinal Change in Gray and White Matter Tissues | This outcome will be evaluated by neuroimaging. Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years | Participants |
| Secondary | Longitudinal Change of Individual Variation and Risk Factors in Gray and White Matter Tissues | Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years | Participants |
| Secondary | Change Over Time in Imaging Metrics | Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years | Participants |
| Other Pre-specified | Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy | Baseline is the last FDG-PET and MET-PET prior to initiation of radiation therapy. | Not Posted | Baseline | Participants |
| Other Pre-specified | Longitudinal Change of Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy | Correlation of avidity of ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET prior to radiation therapy with progression-free survival will be reported | Not Posted | 12, 24 and 36 months after second course of irradiation | Participants |
| Other Pre-specified | Longitudinal Change of Necrosis Measured With MET/FDG and Necrosis Measured With MRI | Association between necrosis measured with MET/FDG vs. MRI Baseline is defined as day 1 of radiation therapy (RT). | Not Posted | Baseline, and at 12, 24 and 36 month | Participants |
| Other Pre-specified | Mean Change Over Time in Cytokine Levels | Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline through 5 years after radiation therapy | Participants |
| Other Pre-specified | Genetic Variations in Germline | Evaluate will be of genetic variations in germline associated with treatment response and side effects. P-values will be reported. Baseline is defined as day 1 of radiation therapy. | Not Posted | Baseline | Participants |
| Other Pre-specified | 3-year Progression-free Survival (PFS) Rates by Chemotherapy Groups | Not Posted | 2 years after initiation of irradiation for the last patient enrolled | Participants |
| Other Pre-specified | 3 Year Overall Survival (OS) Rates by Chemotherapy Groups | Not Posted | 2 years after initiation of irradiation for the last patient enrolled | Participants |
| 8 |
| 64 |
| 2 |
| 64 |
| 30 |
| 64 |
|
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment | Unrelated to radiation therapy, pre-existing swallowing issues developed post-operatively prior to radiation therapy; cause of death unknown as autopsy not performed. |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
| Other-Pseudomeningocele | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral nerve infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Central nervous system necrosis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | New diagnosis/onset of seizures. |
|
| Other - Bradypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
| Other - Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Associated with administration of 11C-Methionine, observed post-11C-Methionine PET scan, not radiation-related. |
|
Not provided
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003837 |
| Deoxy Sugars |
| D002241 | Carbohydrates |
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D063193 | Heavy Ion Radiotherapy |