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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

3 Years - 29 Years

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Proton Radiation Therapy — RADIATION
  Undergo 3D-CPRT
• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo 3D-CRT
• Biospecimen Collection — PROCEDURE
  Undergo blood and CSF sample collection
• Carboplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Intensity-Modulated Proton Therapy — PROCEDURE
  Undergo IMPT
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Lumbar Puncture — PROCEDURE
  Undergo LP
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Questionnaire Administration — OTHER
  Ancillary studies
• Surgical Procedure — PROCEDURE
  Undergo second-look surgery

Study Details

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.

Key Dates

Start date

Oct 22, 2024

Status verified

Apr 2026

Primary completion

Nov 4, 2033

Completion

Nov 4, 2033

Study Design

Enrollment

240 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery)
  See Detailed Description.
• Experimental: Stratum II (carboplatin, etoposide, 3D-CRT, IMRT)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
• Experimental: Stratum III (carboplatin, etoposide, 3D-CRT, IMRT)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
• Experimental: Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
• Experimental: Stratum V (carboplatin, etoposide, 3D-CRT, IMRT)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
• Experimental: Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
• Experimental: Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)
  Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Primary Outcome Measure

Event-free survival (EFS) (Stratum I) [ Time Frame: Evaluated at 2- and 3-years post-radiation initiation ]

Locations (92)

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