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Title:
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
Protocol Number:
PACNS0331
Phase:
Phase III
Physician:
Kenneth Cohen
Purpose:
-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.
Eligibility:
-Age 3-22 years -Posterior fossa medulloblastoma -Good health -Normal labs
Treatment:
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.
Population:
Both
Last Update
05/23/2013 04:06 AM
 

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