Conventional vs accelerated fractionation in head and neck cancer.

From October 1990 to March 1994, 90 patients entered a prospectively randomised trial in head and neck cancer. All patients had verified squamous cell carcinoma and were referred for primary radiation therapy. Tumours originated in the oral cavity in 25, oropharynx in 37, larynx in 15 and hypopharynx in 13 cases. Patients' stages were predominantely T3 and T4 (71/90) and had lymph node metastases (60/90). Seventy-nine male patients and 11 female patients, with a median age of 57 years (range 37-76 years) were treated. Patients were randomised to one of three treatment options: conventional fractionation (CF) consisting of 70 Gy in 35 fractions over 7 weeks or continuous hyperfractionated accelerated radiation therapy (Vienna-CHART) or Vienna-CHART with administration of a single dose of mitomycin C on day 5 of treatment (V-CHART + MMC). By the accelerated regimen a total dose of 55.3 Gy was given in 33 fractions within 17 consecutive days. Acute mucositis was the main toxicity recorded in those patients treated by accelerated fractionation, although the overall duration of mucosal reaction did not differ in the three treatment groups. There was no influence on local toxicity if MMC was added to radiation therapy or not. Those patients treated with additional MMC experienced a grade III/IV haematological toxicity in 4/28 cases. Complete remission (CR) was recorded in 48% following CF, 79% after Vienna-CHART (P < 0.05) and 71% after Vienna-CHART + MMC. The overall local failure rates were 73%, 59% and 42% (P = NS) for patients treated by CF, Vienna-CHART and Vienna-CHART + MMC respectively.

RCT Entities:   Population Interventions Outcomes