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Chemotherapy + Radiation for Medulloblastoma
Study Summary
This trial is testing different combinations of chemotherapy and radiation therapy to compare how well they work in treating patients with newly diagnosed, high-risk medulloblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
Are adults within the age range of 20-25 years eligible for this research opportunity?
"477 other clinical trials focus on children under 18 whereas this study is seeking applicants that are between the ages of 3 and 21. In contrast, there are 1818 medical trials for adults over the age of 65."
What are we trying to learn by conducting this clinical trial?
"The primary outcome of this clinical trial, which will be evaluated over approximately Up to 5 years is to Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET). Secondary outcomes include Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients which is defined as Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the"
What are some of the most common maladies that Cisplatin has been shown to improve?
"Cisplatin is often used as a first-line treatment, but it is also effective in treating small cell lung cancer, advanced testicular cancer, and other lung cancers."
Has Cisplatin been looked at before in other research?
"Cisplatin was first trialled in 1997 at City of Hope Comprehensive Cancer Center. Out of the 3697 completed clinical trials, 2103 are still recruiting patients. The great majority of these trials are being conducted in Birmingham, Alabama."
Do you have any information about whether this research is still looking for participants?
"This research is not currently recruiting patients. The first posting was on March 26th, 2007, with the most recent update on January 4th, 20212. If you are looking for other studies, there are presently 76 studies actively searching for patients with medulloblastoma and 2103 trials for Cisplatin actively admitting patients."
Has Cisplatin been approved by the FDA for medication use?
"Cisplatin is considered safe, with a score of 3, because it has been through multiple rounds of testing and there is some data supporting its efficacy."
Are there any specific medical requirements for this clinical trial?
"This study is enrolling 379 patients with medulloblastoma between the ages of 3 and 21. Most importantly, patients must meet the following criteria: - They cannot be taking any strong inhibitors or inducers of cytochrome P450 3A4. Examples of these drugs include azole antifungals and rifampin.- They must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks.- They must be newly diagnosed and previously untreated"
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