New hope for young brain tumor patients: chemotherapy first, then targeted radiation
NCT ID NCT00602667
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This clinical trial tests a risk-adapted approach for young children with newly diagnosed brain tumors. The treatment starts with chemotherapy to delay radiation, giving the brain more time to develop. Then, radiation is carefully targeted to the tumor area to reduce side effects on thinking and learning. The study includes children with several tumor types, such as medulloblastoma and high-grade glioma, and aims to improve survival while protecting brain function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (methotrexate, vincristine, cisplatin, cyclophosphamide) and radiation therapy
- What this could lead to
- If successful, this approach could improve survival rates for young children with brain tumors while reducing long-term thinking and learning problems.
- What could go wrong
- This is a Phase 2 trial, so results are still preliminary. The combination of chemotherapy and radiation may still cause side effects, and not all tumor types may respond equally.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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293 people
The number who actually took part.
- Started
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Dec 2007
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 5 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Histologically confirmed newly diagnosed CNS tumors of any of the following : * Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma) * Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma) * Pineoblastoma * Atypical teratoid rhabdoid tumor (ATRT) * Choroid plexus carcinoma * High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma, * Ependymoma (including all ependymoma histological variants) * Age \< 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and \< 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible. * Meets criteria for 1 of the following risk groups: * Low-risk group: * Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity * Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist * No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF) * Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated * Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible * Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of \< 1 cm2 confirmed on postoperative CT scan or MRI * Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \< 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk * Desmoplastic medulloblastoma patients who are ≥3 -\<5 years of age will NOT be eligible for the low risk arm of the protocol. * Intermediate-risk group: * Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis * Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis * Medulloblastoma patients who are ≥3 and \< 5 yrs of age irrespective of histology and with no evidence of CNS metastasis * High-risk group: * Any eligible histologic diagnosis with evidence of CNS metastasis * Patients with extraneural metastasis are eligible for treatment on the high-risk group PATIENT CHARACTERISTICS: * Lansky performance status ≥ 30 (except for posterior fossa syndrome) * WBC \> 2,000/mm3 * Platelets \> 50,000/mm3 (without support) * Hemoglobin \> 8 g/dL (with or without support) * ANC \> 500/mm3 * Serum creatinine \< 3 times upper limit of normal (ULN) * ALT \< 5 times ULN * Total bilirubin \< 3 times ULN PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 31 days since prior definitive surgery * No prior radiotherapy or chemotherapy other than corticosteroid therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospitals and Clinics of Minnesota - St. Paul
Saint Paul, Minnesota, 55102, United States
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Lady Cilento Children's Hospital, Brisbane
Brisbane, Queensland, 4029, Australia
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Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 94304, United States
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Rady Children's Hospital
San Diego, California, 92123, United States
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
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