At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed primary CNS pure germ cell tumor diagnosed within the past 31 days
- ✓Age 3 to 25 years
- ✓Localized disease (M0) or disseminated disease (M+) meeting specific staging criteria
- ✓Serum β-HCG ≤ 50 IU/dL, serum AFP ≤ 10 IU/L and ≤ institutional norm, CSF AFP ≤ 2.0 IU/L and ≤ institutional norm
- ✕Prior chemotherapy, radiotherapy, or other therapy for germ cell tumor (prior surgery allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma
In Brief
A Phase 3 clinical trial evaluating filgrastim, carboplatin, and 4 other interventions for Brain Tumor and Central Nervous System Tumor. Completed, enrolled 24 participants across 107 sites in 4 countries.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor. PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.
Study Details
Timeline
Interventions
Given by infusion or injection
Given IV over 1 hour
Given IV over 6 hours
Given IV over 1 hour
Given IV over 2 hours
Patients undergo radiotherapy 5 days a week