Study on Lowering Radiation Dose to Treat Children with CNS Germinoma

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06368817

Provider View

This clinical trial is exploring whether using a lower dose of radiation after chemotherapy can effectively treat children with central nervous system (CNS) germinomas, while reducing long-term side effects.

Patient Parameters

Program Overview

This study is testing if a lower dose of radiation therapy, given after chemotherapy, can effectively treat children with CNS germinomas. Radiation therapy uses high-energy rays to kill cancer cells. The chemotherapy drugs used are carboplatin and etoposide, which work by stopping the growth of cancer cells. Researchers hope that by reducing the radiation dose, they can still treat the cancer effectively but with fewer long-term side effects.

Description

The main goal of this study is to see if a lower dose of radiation can work as well as the standard dose in treating children with localized CNS germinomas. The study will also look at how well patients do over time without the cancer coming back and how the treatment affects their overall health and brain function.

The study is divided into different groups based on the type and response of the tumor:

  • Group 1: Patients with localized germinoma who respond well to chemotherapy will receive a lower dose of radiation.
  • Group 2: Patients with localized germinoma who have a partial response to chemotherapy will receive a slightly higher dose of radiation.
  • Group 3: Patients with localized germinoma who do not respond well to chemotherapy will receive the standard dose of radiation.
  • Group 4 and 5: Patients with metastatic germinoma will receive radiation based on their response to chemotherapy.
  • Group 6 and 7: Patients with germinoma in specific brain areas will receive radiation based on their response to chemotherapy.

All patients will have regular MRI scans and may provide blood and tissue samples for research. After treatment, patients will have follow-up visits to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Children and young adults aged 3 to under 30 years.
  • Newly diagnosed with localized CNS germinoma in specific brain areas.
  • Certain tumor markers in blood or spinal fluid must be within specific ranges.
  • Must have a good performance status, meaning they can carry out daily activities.
  • Must have recent imaging studies and tumor marker tests.
  • Must have adequate blood counts and organ function.
  • Must not have received any prior treatment for germinoma other than surgery or steroids.
  • Must agree to use effective birth control during the study if of childbearing potential.

Exclusion Criteria

  • Patients with certain types of malignant tumors are not eligible.
  • Patients who have only mature teratoma and negative tumor markers are not eligible.
  • Patients who have received prior treatment for germinoma other than surgery or steroids are not eligible.
  • Pregnant or breastfeeding females are not eligible.
  • Sexually active patients must agree to use effective contraception.
  • All participants must provide informed consent.

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