At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed medulloblastoma in posterior fossa with standard-risk disease
- ✓Minimal residual tumor ≤1.5 cm² on post-operative MRI with contrast within 21 days after surgery
- ✓No metastatic disease confirmed by spine MRI (within 5 days before or 28 days after surgery) and negative CSF cytology after surgery
- ✓Brain stem involvement is allowed
- ✕Prior chemotherapy
- ✕Prior radiotherapy
- ✕Pregnant or nursing females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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: A Phase III Double Randomized Trial
In Brief
A Phase 3 clinical trial evaluating Cisplatin, Craniospinal Irradiation, and 7 other interventions for Medulloblastoma. Completed, enrolled 549 participants across 197 sites in 7 countries.
Signals
Detailed Summary
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for 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 is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.
Study Details
Timeline
Arms & Interventions
See Detailed Description (Arm I)
See Detailed Description (Arm II)
See Detailed Description (Arm III)
See Detailed Description (Arm IV)
See Detailed Description (Arm V)
See Detailed Description (Arm VI)
Interventions
Given IV
Undergo craniospinal Irradiation
Given IV
Undergo smaller volume boost (involved-field radiation therapy)
Correlative studies
Given orally
Ancillary studies
Undergo standard volume boost (whole posterior fossa radiation therapy)
Given IV