TerminatedPhase 2

Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma

Stopped: The study was terminated prematurely due to slow accrual.

United States30 participantsStarted 2001-04

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but also damages normal cells in the developing brains of children. Combining low-dose radiation therapy in combination with chemotherapy should be effective in treating medulloblastoma while avoiding the long-term side effects of giving higher dose radiation to children with newly diagnosed average risk medulloblastoma.

Who can participate

Age range3 Years – 30 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed medulloblastoma
✓. Standard-risk disease
✓. No residual tumor greater than 1.5 cm\^2 after resection by postoperative MRI
✓. Must begin radiotherapy on study within 28 days after surgery

Exclusion criteria

✕. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
✕. Pregnant females will not be eligible
✕. Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
✕. Patients with the following will not be eligible:

What they're measuring

Evaluate Rate of Late Neurotoxic Effects

Timeframe: 3 years

Trial details

NCT IDNCT00031590

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2018-07-25

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