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: A Phase III Double Randomized Trial
-To find out if there is anything that might identify which children may relapse with different radiation treatment boost volumes. -To reduce the effects of radiation on young childrens hearing, ability to learn, and hormone function by reducing the dose of radiation delivered to the brain and spine. -To look at whether children given a smaller volume boost dose of radiation have fewer problems with their hearing and hormone function compared to children that receive the standard-volume boost dose. -To identify tumor specific traits that can predict how a child with medulloblatomas cancer may progress.
-Age 3-22 years -Posterior fossa medulloblastoma -Good health -Normal labs
In order to compare the effects of different doses and volumes of radiation, children will be randomized to different treatment plans at the time of study entry. Children between the ages 3 and 8 will be randomized twice. They will be randomized between two doses of craniospinal radiation and between a standard volume boost and a smaller volume boost. All children 8 years and older will be given the standard dose of craniospinal radiation and will only be randomized for the boost volume of radiation. Chemoradiotherapy begins about 4 weeks after surgery. Radiation therapy to the brain and spine will be given 5 days each week for 6 weeks. Chemotherapy V equal to Vincristine will be given directly into the vein (for less than a minute) once a week for 6 weeks beginning at Week 1 (one week after the start of radiation). Maintenance chemotherapy begins 4 weeks after the completion of chemoradiotherapy. There will be 9 cycles of maintenance. There are two different kinds of cycles given. They are referred to as A and B. Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. As shown on the calendar above, B cycles are given after the completion of 2 A cycles. Below are the details of the drugs and schedules for A and B cycles.
05/23/2013 04:06 AM