A randomized trial of combined modality therapy of childhood non-Hodgkin's lymphoma.

From 1975 to 1978, 69 children with non-Hodgkin's lymphoma were staged and treated in a randomized protocol to determine the contribution of involved-field radiotherapy (IF-RT) to an effective drug regimen in Stages III-IV and the efficacy of prophylactic treatment of the central nervous system with cranial irradiation and intrathecal methotrexate in Stage II-IV. Induction therapy for Stages I-II was vincristine, prednisone, cyclophosphamide and IF-RT (3000-3500 rad). Stages III-IV received the same three drugs plus adriamycin, and were randomized to received or not receive IF-RT. The complete remission rate was 88%. After randomization to receive CNS prophylaxis or not, all children received oral mercaptopurine and methotrexate for 18 months. The two-year actuarial estimate of disease-free survival for all responders is 55% and is significantly influenced by stage. (Ninety percent disease-free survival for Stages I-II, versus 38.8% for III-IV, P less than .05). We observed no benefit but added toxicity from IF-RT in Stages III-IV. Efforts at CNS prophylaxis in high-risk children are warranted, since only 1 of 18 children randomized to receive prophylaxis developed CNS disease as the site of first relapse, whereas 4 of 16 receiving no prophylaxis did so.

RCT Entities:   Population Interventions Outcomes