A Phase II Trial Evaluating Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas
Children's Oncology Group
Summary
This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.
Description
PRIMARY OBJECTIVE: I. 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). SECONDARY OBJECTIVES:…
Eligibility
- Age range
- 3–29 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 i…
Interventions
- Radiation3-Dimensional Conformal Proton Radiation Therapy
Undergo 3D-CPRT
- Radiation3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
- ProcedureBiospecimen Collection
Undergo blood and CSF sample collection
- DrugCarboplatin
Given IV
- DrugEtoposide
Given IV
- ProcedureIntensity-Modulated Proton Therapy
Undergo IMPT
- RadiationIntensity-Modulated Radiation Therapy
Locations (109)
- USA Health Strada Patient Care CenterMobile, Alabama
- Phoenix Childrens HospitalPhoenix, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas
- Loma Linda University Medical CenterLoma Linda, California
- Children's Hospital Los AngelesLos Angeles, California
- UCSF Benioff Children's Hospital OaklandOakland, California