Head and Neck Cancer Clinical Trial
Official title:
Hyperfractionation and Accelerated Fractionation in Comparison With Conventional Fractionation in Definitive Radiotherapy of Squamous Cell Carcinoma of Larynx, Oropharynx and Hypopharynx
The aim of our study was to evaluate the value of two different altered fractionation schedules – hyperfractionation and accelerated fractionation with concomitant boost – in comparison with conventional fractionation in primary definitive radiotherapy for squamous cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted while the only teletherapy unit in our department was the cobalt-60 machine. During that period we were expecting the installation of new sophisticated equipment. We assumed that the results of this study would be also able to show whether or not it would be rational to use the altered fractionation regimens on the new machines.
Eligible patients admitted from March 1999 to December 2000 were treated with conventionally
fractionated radiotherapy. These patients represented the retrospective part of the study.
Patients admitted between January 2001 and June 2004 were included in the prospective part
of the study. Following the confirmation of their eligibility, altered fractionation
schedule assignment was made after stratifying by site of origin (larynx vs oropharynx vs
hypopharynx), Karnofsky performance score (60%-70% vs 80%-100%), and stage of disease (I and
II vs III and IV). Patients were randomized to receive radiotherapy delivered using either
hyperfractionation or accelerated fractionation with concomitant boost as a late
accelerating component. Exceptions occurred when patients either refused treatment with two
daily fractions or were not offered twice-a-day irradiation because of lack of machine time.
Radiotherapy Scheduling and Technique The conventionally fractionated radiotherapy schedule
was 66-70 Gy in 6½ -7 weeks (one fraction of 2 Gy per day, 5 fractions per week), whereas
the hyperfractionation treatment schedule was 74.4-79.2 Gy in 6.2-7 weeks (two fractions of
1.2 Gy per day, 10 fractions per week with interfraction interval of at least 6 hours;
Figure 1). The treatment schedule in accelerated fractionation using concomitant boost
consisted of daily fraction of 1.8 Gy, 5 days a week, up to 32.4 Gy including all sites of
disease and electively irradiated areas of the neck, followed by two daily fractions for the
last 11-12 days. The first daily fraction encompassed all sites of the disease and
electively irradiated neck nodes using a dose of 1.8 Gy, and the second daily fraction was
the concomitant boost delivered through reduced fields to encompass the gross disease only,
using a fraction of 1.5 Gy up to total doses of 68.7-72 Gy in 6 weeks (Figure 1). The
interval between the two daily fractions was at least 6 hours.
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Observational Model: Defined Population, Time Perspective: Longitudinal
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