Prospective randomised trial of chemotherapy given before radiotherapy in childhood medulloblastoma. International society of paediatric oncology (SIOP) and the (German) society of paediatric oncology (GPO): SIOP II

TLDR

A multicentre randomised trial of 364 children with biopsy‑proven medulloblastoma stratified patients into low‑ and high‑risk groups and randomised low‑risk children to standard (35 Gy) or reduced (25 Gy) craniospinal radiotherapy with or without a 6‑week pre‑RT chemotherapy course of vincristine, procarbazine, and methotrexate, while high‑risk children received additional post‑RT vincristine and CCNU. The study found no benefit from pre‑radiotherapy chemotherapy and observed a negative interaction with reduced‑dose radiotherapy, leading to particularly poor outcomes in that subgroup. © 1995 Wiley‑Liss, Inc.

Abstract

Abstract In a multicentre randomised clinical trial 364 children with biopsy proven medulloblastoma were randomly assigned to receive or not pre‐radiotherapy chemotherapy. Children with total or subtotal removal of the tumour, no evidence of invasive brain stem involvement, and no evidence of metastatic disease either within or without the cranium were designated “low risk”, those with gross residual tumour, evidence of invasive brain stem involvement or metastases in the central nervous system were designated “high risk”. All children were prescribed 55 Gy to the tumour bearing area. “Low risk” children could be randomised to “standard” radiotherapy 35 Gy to the craniospinal axis or “reduced” dose 25 Gy to the craniospinal axis. Chemotherapy consisted of vincristine, procarbazine, and methotrexate given in a 6‐week module before radiotherapy, and for “high risk” children, vincristine and CCNU given after radiotherapy. No benefit for the receipt of pre‐radiotherapy chemotherapy could be demonstrated for any group. In addition, a negative interaction was observed between the receipt of the chemotherapy and reduced dose radiotherapy with a particularly poor outcome being observed in this group of children. © 1995 Wiley‐Liss, Inc.