Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
- Conditions
- High Risk Supratentorial PNETMetastatic MedulloblastomaMetastatic PNET
- Interventions
- Registration Number
- NCT01542736
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Age greater than 3 years and less than 25 years
- Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.
- Patients with high-risk supratentorial, non-metastatic, PNET
- Patients with metastatic PNET
- Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision
- Only patients who are expected to survive at least 6 weeks will be eligible for this study.
- Patients who are pregnant may not be treated on this study
- Patients with anaplastic histology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reduced radiation with concurrent chemotherapy Carboplatin Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Reduced radiation with concurrent chemotherapy 24 Gy Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Reduced radiation with concurrent chemotherapy Vincristine Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
- Primary Outcome Measures
Name Time Method Event-free Survival Up to 60 months. MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Overall Survival up to 5 years Overall Survival will be measured at the end of study. number of surviving participants is reported.
Intellectual Competence Measured by IQ Score: Month 24 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.
Intellectual Competence Measured by IQ Score: Month 60 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.
Intellectual Competence Measured by IQ Score: Week 8 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States