NCT00771641

Fractionated Radiation Therapy in Treating Advanced Squamous Cell Carcinoma of the Head and Neck

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,113 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Detailed description

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 two regimens. 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 closed.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery
RADIATION	low-LET cobalt-60 gamma ray therapy
RADIATION	low-LET electron therapy
RADIATION	low-LET photon therapy
RADIATION	radiation therapy

Timeline

• Primary completion: 2002-08-01
• Completion: 2013-11-01
• First posted: 2008-10-13
• Last updated: 2014-01-24