Phase III Randomized Comparison of Radiotherapy Fractionation in Advanced Squamous Cell Carcinoma of the Head and Neck: Twice-Daily Hyperfractionation vs Split-Course Accelerated Hyperfractionation vs Accelerated Fractionation With Concomitant Boost vs Standard Fractionation
OBJECTIVES: I. Determine whether hyperfractionation and/or accelerated fractionation
(split-course or with a concomitant boost) improves the locoregional control rate over
standard fractionation radiotherapy in patients with advanced squamous cell carcinomas of
the head and neck. II. Determine the disease-free survival and overall survival of these
patients treated with different radiotherapy fractionation schemes. III. Determine the acute
and late toxicities of each fractionation schedule. IV. Compare the quality of life on the
OUTLINE: Randomized study. Arm I: Radiotherapy. Irradiation of primary tumor and involved
and at-risk nodal areas using linear accelerators with photon energies of 1.25-6.0 MV (dual
energy arrangements may also use a beam greater than 6.0 MV), electrons of 4-25 MV, or Co60.
Standard fractionation. Arm II: Radiotherapy. Targets and equipment as in Arm I.
Hyperfractionation. Arm III: Radiotherapy. Targets and equipment as in Arm I. Accelerated
split-course hyperfractionation. Arm IV: Radiotherapy. Targets and equipment as in Arm I.
Accelerated fractionation with concomitant boost.
PROJECTED ACCRUAL: A total of 1,080 patients (270/arm) will be accrued over 5.75 years. If
excessive toxicity is noted in any arm after entry of 324 and 634 patients, that arm may be
Primary Purpose: Treatment
K. Kian Ang, MD, PhD
M.D. Anderson Cancer Center
United States: Federal Government