Single fraction per day versus two fractions per day versus radiochemotherapy in the treatment of head and neck cancer.

From January 1978 to January 1988, 859 patients with T3-T4, NO-3, MO were randomly allocated to receive either: Group A--60Co 60, 60 Gy in 30 fractions; Group B--60Co, 70.4 Gy in 64 fractions; Group C--60Co, 60 Gy in 30 fractions plus chemotherapy (5 Fu, 250 mg/m2/IV every 2 days). Chemotherapy and radiotherapy were combined simultaneously. The average age was 56 years; the male/female ratio was 802/57. Median performance status (ECOG scale) was 1 (range 0-2). The TNM distribution as UICC criteria was T3 529 patients; T4 330 patients; No 217 patients; N1 52 patients; N2 319 patients; and N3 271 patients. The primary sites were nasopharynx 92, oral cavity 252, hypopharynx 119, larynx 310, and others (sinuses and unknown primary)86. Complete response was achieved in 188/277 patients in Group A (67.8%), 254/282 patients in Group B (90%), and 289/300 in Group C (96.3%). All patients were followed and statistical analysis shows a significant improvement in median duration of response, as well as survival for Groups B and C compared with Group A. No significant differences were seen between Group B and C. The acute toxicity was mucositis, skin toxicity, bone marrow depression. A mean temporary weight loss of 4.9 Kg was observed with a range of 2.3-10.5 Kg.

RCT Entities:   Population Interventions Outcomes