ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
All patients must be enrolled within 28 days of surgery, and begin treatment within 14 days of enrollment. Upon enrollment, children will be randomized to two different treatment plans. Children between the ages 3 and 7 will be randomized twice. They will be randomized between (1) two doses of craniospinal radiation therapy and (2) between a standard volume boost and a smaller volume boost of posterior fossa radiation therapy. All children 8 years and older will be given the standard dose of craniospinal radiation and will only be randomized once for the boost volume of radiation therapy to the posterior fossa. As of Amendment #5, the children 8 years of age and older Arn was completed.
The first phase of treatment is chemoradiotherapy. It begins about 4 weeks after surgery, and consists of craniospinal radiation therapy (either an experimental 18 Gy dose or standard 23.4 Gy dose), a boost volume of posterior fossa radiation therapy (either an experimental smaller volume boost or standard volume boost) to the posterior fossa, and chemotherapy. Then, patients will begin maintenance chemotherapy. Maintenance chemotherapy begins 4 weeks after the completion of chemoradiotherapy. There will be 9 cycles of maintenance chemotherapy.
Patients will be closely monitored during and after therapy for cancer response to therapy and outcome and side effects as a result of the treatment. Monitoring includes frequent medical histories and physical exams, laboratory studies (blood counts, serum chemistries, renal function tests, liver function tests, and hormone tests), hearing tests, neuropsychological studies, and MRIs of the brain and spine.
The optional neuropsychological testing for this study is now collected as a part of a companion study: STU 012011-037. Patients who consent to participate in STU 012011-037 will be assessed at three times points: at 9 months (± 3 months) post cancer diagnosis; at 30 months (± 3 months) post diagnosis, and again at 60 months (± 3 months) post diagnosis. Age appropriate tests will be used and will include measures of broad cognitive functioning (IQ) and specific areas of neuropsychological functioning, emotional-behavioral functioning, and quality of life. Total
testing time should be approximately 1 hour at each assessment point.
The optional Quality of Life evaluations will be assessed at three times points: at 9 months (± 3 months) post cancer diagnosis; at 30 months (± 3 months) post diagnosis, and again at 60 months (± 3 months) post diagnosis. Age appropriate tests will be used. Total testing time should be approximately 20 minutes at each assessment point.
(1) Patients will begin treatment within 28 days of definitive surgery and 14 days of fulfilling all eligibility criteria and study enrollment. (2) Patients must be greater than or equal to 3 years and less than 22 years at the time of diagnosis. (3) Patients must have a posterior fossa medulloblastoma as determined by institutional pathologic evaluation. Preoperative and postoperative cranial MRI with and without contrast must be available. Patients with brainstem involvement are eligible. (4) No evidence of metastatic disease in the head, spine, or CSF. (5) Patients must have a performance level of ≥50 using the Karnofsky or Lansky criteria. (6) Patients must have no previous radiotherapy or chemotherapy, other than corticosteroids. (7) Adequate renal, liver, and bone marrow function.