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Hyperfractionation and Accelerated Fractionation in Comparison With Conventional Fractionation in Definitive Radiotherapy of Squamous Cell Carcinoma of Larynx, Oropharynx and Hypopharynx


Phase 1
18 Years
75 Years
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Hyperfractionation and Accelerated Fractionation in Comparison With Conventional Fractionation in Definitive Radiotherapy of Squamous Cell Carcinoma of Larynx, Oropharynx and Hypopharynx


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.


Inclusion Criteria:

The inclusion criteria were age 18-75 years, Karnofsky performance
score equal or more then 60%, and all stages of disease except stage IVC (TNM
classification according to International Union Against Cancer and American Joint
Committee of Cancer (UICC and AJCC) from 1997). -

Exclusion Criteria:Patients with previous or concurrent malignancy other then basal cell
carcinoma were excluded.

-

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Retrospective/Prospective

Principal Investigator

Valentina B Krstevska

Investigator Role:

Principal Investigator

Investigator Affiliation:

2

Authority:

Macedonia: FYR of Macedonia Faculty of Medicine

Study ID:

CF vs HF and AF

NCT ID:

NCT00291434

Start Date:

March 1999

Completion Date:

June 2005

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Fractionation
  • Radiotherapy
  • Conventional fractionation
  • Hyperfractionation
  • Accelerated fractionation
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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