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

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1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00085735?term=A+Study+Evaluating+Limited+Target+Volume+Boost+Irradiation+and+Reduced+Dose+Craniospinal+Radiotherapy+%2818.00+Gy%29+and+Chemotherapy+in+Children+with+Newly+Diagnosed+Standard+Risk+Medulloblastoma%3A+A+Phase+III+Double+Randomized+Trial.&rank=1

2. Intervention

   Cisplatin

3. Intervention

   Cyclophosphamide

4. Intervention

   Lomustine

5. Intervention

   Vincristine sulfate

6. Intervention

   Radiation therapy

7. Additional Topic(s)

   Antineoplastic combined chemotherapy protocols

8. Additional Topic(s)

   Radiotherapy

9. Resource Description

   The purpose of this study is to find out if the overall dose of radiation to the brain and spine can be reduced without decreasing the survival rates. The study will also look at whether the volume of radiation given during the “boost” to the specific area of the tumor can safely be reduced without decreasing survival. Additional goals of this study are to: To identify whether children who receive less radiation and have their tumors come back share similar characteristics. To reduce the effects of radiation on the child’s hearing, ability to learn, and hormone function. To look at whether children who receive lower doses of radiation have fewer long-term side effects of treatment. To perform studies on removed tumor in the laboratory that may predict prognosis.

10. Contact

    Berenberg, Jeffrey

11. PI

    Wilkinson, Robert, M.D.

12. Topic

    medulloblastoma

13. Study Population

    Males and females between the ages of 3 and 21 at the time of diagnosis with histologically confirmed medulloblastoma located in the posterior fossa.

14. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=365506&version=healthprofessional

15. Website(s)

    http://www.curesearch.org/ArticleView2.aspx?id=7334&l=8673

16. Funded by

    Children's Oncology Group

17. Phase

    Phase 3 clinical trial

18. Performed by

    Clinical Protocol & Data Management Shared Resource