Current Research: Pediatric Hematology-Oncology

ACNS0331 --  A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.
This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.

Eligibility

Patients may be eligible for this trial if:

• The patient is between 3 and 21 years old
• No previous radiotherapy or chemotherapy other than corticosteroids.
• Presence of a posterior fossa medulloblastoma as determined by institutional pathologic evaluation. Preoperative and postoperative cranial MRI with and without contrast must be available.
• Patients with anaplastic medulloblastoma will not be eligible.
• Patients with brain stem involvement are eligible.
• Presence of minimal volume, non-disseminated disease, as defined by the following criteria:
  1. There must be unequivocal evidence that the maximal cross-sectional area of residual tumor is 1.5 cm2 or less on MRI, performed with contrast imaging (preferably within 48 hours, and at most 28 days following surgery) upon elimination of the tumor in all three phases.
  2. No evidence of metastatic disease in the head, spine, or CSF.
     • Assessment must include a pre-operative (within 5 days prior to surgery) or postoperative enhanced MRI of the spine within 28 days after surgery
     • Cytological examination of CSF performed after surgery but before the time of enrollment.
• False positive cytology can occur within 10 days of surgery. Patients with positive CSF cytology obtained before 10 days after surgery may have cytology repeated to determine eligibility.

Trial Sponsor

• Children’s Oncology Group (COG)

Project Begin Date

• Nov 2004

Tentative Project End Date

• Dec 2009

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .