From October 1990 to March 1994, 90 patients entered a prospectively r
andomised trial in head and neck cancer. All patients had verified squ
amous 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 predominantel
y T3 and T4 (71/90) and had lymph node metastases (60/90). Seventy-nin
e 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 t
hree treatment options: conventional fractionation (CF) consisting of
70 Gy in 35 fractions over 7 weeks or continuous hyperfractionated acc
elerated radiation therapy (Vienna-CHART) or Vienna-CHART with adminis
tration 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 fractionat
ion, although the overall duration of mucosal reaction did not differ
in the three treatment groups. There was no influence on local toxicit
y if MMC was added to radiation therapy or not. Those patients treated
with additional MMC experienced a grade III/IV haematological toxicit
y 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 pati
ents treated by CF, Vienna-CHART and Vienna-CHART+MMC respectively.