PROSPECTIVE RANDOMIZED TRIAL OF CHEMOTHERAPY GIVEN BEFORE RADIOTHERAPY IN CHILDHOOD MEDULLOBLASTOMA - INTERNATIONAL-SOCIETY-OF-PEDIATRIC-ONCOLOGY (SIOP) AND THE (GERMAN)-SOCIETY-OF-PEDIATRIC-ONCOLOGY (GPO) - SIOP-II

In a multicentre randomised clinical trial 364 children with biopsy pr oven medulloblastoma were randomly assigned to receive or not pre-radi otherapy chemotherapy. Children with total or subtotal removal of the tumour, no evidence of invasive brain stem involvement, and no evidenc e of metastatic disease either within or without the cranium were desi gnated ''low risk'', those with gross residual tumour, evidence of inv asive brain stem involvement or metastases in the central nervous syst em were designated ''high risk''. All children were prescribed 55 Gy t o the tumour bearing area. ''Low risk'' children could be randomised t o ''standard'' radiotherapy 35 Cy to the craniospinal axis or ''reduce d'' dose 25 Cy to the craniospinal axis. Chemotherapy consisted of vin cristine, procarbazine, and methotrexate given in a 6-week module befo re radiotherapy, and for ''high risk'' children, vincristine and CCNU given after radiotherapy. No benefit for the receipt of pre-radiothera py chemotherapy could be demonstrated for any group. In addition, a ne gative interaction was observed between the receipt of the chemotherap y and reduced dose radiotherapy with a particularly poor outcome being observed in this group of children. (C) 1995 Wiley-Liss, Inc.