Radiotherapy Alone versus Chemotherapy Followed by Response-Based Radiotherapy for Newly Diagnosed Primary CNS Germinoma
[Protocol 07-167]
Full Title :
RADIOTHERAPY ALONE VS. CHEMOTHERAPY FOLLOWED BY RESPONSE -BASED RADIOTHERAPY FOR NEWLY DIAGNOSED PRIMARY CNS GERMINOMA (COG-ACNS 0232)
Purpose :
Germinomas of the central nervous system (brain and spinal cord) are most often treated with large doses of radiation. The cure rate is very high, but such treatment can cause late effects: problems that arise later in life after treatment is completed. These effects may include learning and memory problems that affect daily life, and low hormone levels in the blood (which may affect physical growth and sexual development).
In this study, researchers want to determine if using chemotherapy and lower doses of radiation can result in the same cure rate as conventional radiation therapy alone but cause fewer late effects. They will also see if the level of a protein called HCG in the blood or cerebrospinal fluid can be used to monitor how well the treatments will work. Finally, they will determine if the spread of the tumor at diagnosis makes cure less likely.
Patients in this phase III Children's Oncology Group study will be randomly assigned to receive either the conventional dose of radiation or the investigational regimen of chemotherapy with lower dose radiation. Each treatment has been shown in other smaller studies to cure patients with germinoma.
Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
Patients must be newly diagnosed with primary central nervous system germinoma.
Patients may not have had any prior therapy other than surgery.
Patients must be between the ages of 3 and 25 (inclusive).
For more information and to inquire about eligibility for this study, please contact Dr. Ira Dunkel at 212-639-2153 or Dr. Suzanne Wolden at 212-639-5148.