Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Patients with hCGbeta 51-100 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. Histologic confirmation of germinoma IS required

Disqualifiers

Endodermal sinus (yolk sac)

Embryonal carcinoma, choriocarcinoma

Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)

Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible

Trial design

Treatments tested in this trial

  • 3-Dimensional Conformal Proton Radiation Therapy
  • 3-Dimensional Conformal Radiation Therapy
  • Biospecimen Collection
  • Carboplatin
  • Etoposide
  • Intensity-Modulated Proton Therapy
  • Intensity-Modulated Radiation Therapy
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Questionnaire Administration
  • Surgical Procedure

Treatment groups

240 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

109
Australia
John Hunter Children's Hospital2310, Hunter Regional Mail CentreNew South Wales, Australia
Sydney Children's Hospital2031, RandwickNew South Wales, Australia
The Children's Hospital at Westmead2145, WestmeadNew South Wales, Australia
Queensland Children's Hospital4101, South BrisbaneQueensland, Australia

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

Source ClinicalTrials.gov