RANDOMIZED TRIAL WITH EARLY-STAGE HODGKINS-DISEASE TESTING 30 GY VS 40 GY EXTENDED FIELD RADIOTHERAPY ALONE

Purpose: To evaluate whether or not a total dose (TD) of 30 Gy is suff icient for treatment of assumed subclinical Hodgkin's Disease compared to 40 Gy TD with early stage Hodgkin's Disease (ESHD). Methods and Ma terials: In a prospective multicenter trial, 376 patients with laparot omy-proven ESHD stages PS IA to PS IIB without risk factors such as la rge mediastinum, massive splenic involvement, extranodal disease, elev ated erythrocyte sedimentation rate (ESR), and/or three or more involv ed lymphnode areas were randomly allocated either to receive (ARM A) 4 0 Gy TD extended field-radiotherapy (EF-RT) or (ARM B) 30 Gy TD EF-RT plus 10 Gy TD involved field-radiotherapy (IF-RT), both arms without a ny chemotherapy. Three hundred sixty-six of these patients were evalua ble for early and long-term response, such as remission status, freedo m from treatment failure (FFTF), and overall survival (OAS). For quali ty control, all planning and verification films as well as dose charts mere prospectively reviewed by a panel of four experts, all heads of a radiotherapy department, where protocol violations (PV) were seen ei ther with regard to errors in treatment technique, treatment volume, i n TD and/or in dose/time-relationship. Results: Treatment resulted in a complete remission (CR) of 98%; in a 5-year FFTF of 76%, and a 5-yea r OAS of 97%. There was no difference between the two arms in favor of 40 Gy EF compared to 30 Gy EF regarding FFTF and GAS, without any in field relapse throughout the EF volumes. Expectedly, 5-years FFTF was significantly influenced by the quality of radiotherapeutical procedur es: 70% with protocol violations (PV) vs. 82% without PV. Conclusion: Subclinical involvement in ESHD without risk factors is sufficiently t reated by a TD of 30 Gy without chemotherapy, leading to a 5-years FFT F of 82% and a 5-year OAS of 97% in a multicenter treatment setting, w here quality assurance is mandatory. Copyright (C) 1996 Elsevier Scien ce Inc.