This study is currently not recruiting participants.

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

Investigating Radiation Therapy Doses in Treating Medulloblastoma in Children

Not Recruiting
3 years - 21 years
All
Phase N/A

Brief description of study.

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.

Detailed description of study

The purpose of this study is to compare event-free and overall survival of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose vs reduced-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide and to compare event-free and overall survival of these patients (8 to 21 years of age) treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Brain tumor,central nervous system tumor
  • Age: 3 years - 21 years
  • Gender: All

This study investigates the effects of different doses of radiation therapy in children with standard-risk medulloblastoma, a type of brain cancer. Medulloblastoma is a tumor that starts in the brain's cerebellum, which controls movement and balance. The purpose of this study is to see how well standard-dose radiation therapy works compared to a reduced-dose when given with chemotherapy. It also looks at how effective different types of radiation boosts are when added to the treatment.

Participants will receive chemotherapy drugs, including vincristine, cisplatin, lomustine, and cyclophosphamide. Some will get standard-dose radiation to the whole brain and spine, while others receive a reduced dose. Additionally, some participants will receive a boost of radiation to the entire posterior fossa area of the brain, while others will get a boost only to the tumor bed, which is the area where the tumor was removed.

  • Who can participate: Children aged 3 to 21 years with newly diagnosed standard-risk medulloblastoma may participate. Key eligibility includes having undergone surgery for the condition and being able to undergo radiation and chemotherapy.
  • Study details: Participants will be randomly assigned to receive either standard or reduced-dose radiation therapy, along with chemotherapy. Some will receive additional radiation to the posterior fossa, while others will receive it to the tumor bed only. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 0406-04 (ACNS0331)

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