Prospective randomized cooperative medulloblastoma trial (MED 84) of the International Society of Paediatric Oncology (SIOP) and of the (German) Society of Paediatric Oncology (GPO).
This international, prospective, randomised therapeutic study is based on previous, separate studies of the two societies. The study asks two principal questions: Is it possible to improve the results of therapy by inserting, between surgery and post-operative irradiation, an intensive course of chemotherapy consisting of vincristine, procarbazine and methotrexate, followed by citrovorum factor rescue? In "low risk" patients (i.e. those with macroscopically "complete" resection and absence of metastases at diagnosis), can the radiotherapy to CNS areas outside the primary tumour site be reduced by 10 Gy with the aim of reducing late sequelae of irradiation but without compromising survival results? The study also aims at standardising diagnostic methods, neurosurgical procedure and radiotherapeutic technique employed in this tumour. For statistical reasons, results can only be disclosed after the end of the recruitment phase. It is intended to include approximately 350 patients in the study, which is planned to continue until the end of 1988.
Neidhardt
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Bailey
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D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002528:Cerebellar Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D002648:Child; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D006801:Humans; D008527:Medulloblastoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D011446:Prospective Studies; D011897:Random Allocation