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The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced radiation with concurrent chemotherapy | Experimental | Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Administered concurrently with craniospinal radiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | MRIs of the head and spine. Number of participants with event free survival at 60 months is reported. | Up to 60 months. |
| Overall Survival | Overall Survival will be measured at the end of study. number of surviving participants is reported. | up to 5 years |
| Intellectual Competence Measured by IQ Score: Week 8 | Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Week 8 |
| Intellectual Competence Measured by IQ Score: Month 24 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Month 24 |
| Intellectual Competence Measured by IQ Score: Month 60 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Madden, RN, CPNP | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Radiation With Concurrent Chemotherapy | Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation. |
| 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 | Yes | No | No | Study Protocol | Aug 7, 2014 | Dec 13, 2021 |
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| Vincristine | Drug | Administered concurrently with craniospinal radiation. |
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| 24 Gy | Radiation | Craniospinal radiation. |
|
| Month 60 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Radiation With Concurrent Chemotherapy | Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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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 | Event-free Survival | MRIs of the head and spine. Number of participants with event free survival at 60 months is reported. | Posted | Count of Participants | Participants | Up to 60 months. |
|
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| Primary | Overall Survival | Overall Survival will be measured at the end of study. number of surviving participants is reported. | Posted | Count of Participants | Participants | up to 5 years |
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| Primary | Intellectual Competence Measured by IQ Score: Week 8 | Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Not all participants were feeling well enough to complete testing at this timepoint. | Posted | Mean | Full Range | score on a scale | Week 8 |
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| Primary | Intellectual Competence Measured by IQ Score: Month 24 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Not all participants were feeling well enough to complete testing at this timepoint. | Posted | Mean | Full Range | score on a scale | Month 24 |
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| Primary | Intellectual Competence Measured by IQ Score: Month 60 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Not all participants were feeling well enough to complete testing at this timepoint. | Posted | Mean | Full Range | score on a scale | Month 60 |
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Until time of death or progression (Up to 10 years)
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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 | Reduced Radiation With Concurrent Chemotherapy | Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation. | 1 | 8 | 1 | 8 | 1 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to multi-system organ failure | Infections and infestations | Non-systematic Assessment | Death was related to infection and occurred off-treatment. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Raybin, PhD | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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| Unknown or Not Reported |
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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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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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