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Konkomitantna radiokemoterapija z mitomycinom C in cisplatinom pri neoperabilnem karcinomu glave in vratu: raziskava faze I-II = Concomitant radiochemotherapy with mitomycin C and cisplatin in inoperable carcinoma of the head and neck: phase I-II study
Strojan, Primož ...
The Purpose of Phase I-II study was to evaluate concomitant radiochemotherapy with mitomycin C and cisplatin in inoperable carcinoma of the head and neck. The patients were treated with conventional ...radiotherapy (35 x 2 Gy/day), mitomycin C (15 mg/mz IV, after 10 Gy) and cisplatin applied during the last 10 days of irradiation. The daily dose of cisplatin was esca lated from 10 mg/mz to 12 mg/m2 to 14 mg/mZ IV, in order to determine the maximum tolerated dose and maximum acceptable level of intensity of the regimen. Results: Six patients were treated at each dose level. Fourteen (78%) tumors were classified as T4 and 7 (39%) as N3. Dose-limiting toxicity was not recorded and the daily cisplatin dose of 14 mg/mz was chosen as the maximum tolerated dose. Disease-free survival at 12 months of follow up was 36% and the overall survival rate was 45%. Conclusion: The tested regimen was not associated with unacceptable toxicity and the survival results are encouraging enough to be tested in the continuation of phase II clinical study.
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