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; Jones, Jamie; Singh, Sarah H
Trial Phone: 321-843-1036 ; 321-841-8271 ; 321-843-5284 ; 321-842-8738 ; 3218412008 ; 321.841.7561
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IRB No: ACNS2321
Protocol Abbrev: ACNS2321
Principal Investigator:
Phase: Drug: Phase II
Age Group: Pediatric
Treatment: Radiation: 3-Dimensional Conformal Radiation Therapy, Procedure: Biospecimen Collection, Drug: Carboplatin, Drug: Etoposide, Radiation: Intensity-Modulated Radiation Therapy, Procedure: Lumbar Puncture, Procedure: Magnetic Resonance Imaging, Other: Questionnaire Administration, Procedure: Surgical Procedure
Therapies Involved: Chemotherapy; Radiation
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).
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Key Eligibility
- Patients must be ≥ 3 years and < 30 years at the time of study enrollment
- Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required
- Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required
