A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma

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.

Conditions

• Basal Ganglia Germinoma
• Diabetes Insipidus
• Germinoma
• Pineal Region Germinoma
• Suprasellar Germinoma
• Thalamic Germinoma

Interventions

RADIATION

3-Dimensional Conformal Proton Radiation Therapy

Undergo 3D-CPRT

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

DRUG

Carboplatin

Given IV

DRUG

Etoposide

Given IV

PROCEDURE

Intensity-Modulated Proton Therapy

Undergo IMPT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Lumbar Puncture

Undergo LP

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Surgical Procedure

Undergo second-look surgery

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Mohamed S Abdelbaki · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-22

Primary Completion

2033-11-04

Completion

2033-11-04

FDA Drug

Yes

Countries

• United States
• Australia
• Canada

Study Locations