A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
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Clinical Trial Information
Trial Contact: Parker, Melanie; Torrescano, Tanner; Armatti, Julie M; Frankos, Marie
Trial Phone: 321-843-1036 ; 321-841-8271 ; 321-843-5284 ; 321-842-8738
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IRB No: ACNS2321
Protocol Abbrev: ACNS2321
Principal Investigator:
Phase: Drug: Phase II
Age Group: Pediatric
ClinicalTrials.gov ID: NCT06368817
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Objective
To determine whether 12 Gy whole ventricular irradiation (WVI) and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival (EFS) in eligible patients with localized primary central nervous system (CNS) germinoma who present with serum and/or cerebrospinal fluid (CSF) human chorionic gonadotropin-beta (hCGbeta) ≤ 100 IU/L and normal alpha-fetoprotein (AFP), and meet complete response (CR) or continued complete response (CCR) criteria following chemotherapy/second-look surgery (Stratum 1).