Head and Neck Cancer Clinical Trial
Official title:
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
known which radiation therapy regimen is more effective in treating patients with stage II
cancer of the vocal cord.
PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating
patients who have stage II cancer of the vocal cord.
OBJECTIVES:
- Compare the local response rate in patients with stage II invasive squamous cell
carcinoma of the true vocal cord treated with hyperfractionation vs conventional
fractionation radiotherapy.
- Compare the acute and late toxic effects of these regimens in this patient population.
- Compare the overall and disease-free survival patterns in this patient population
treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs
T2b). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by
boost radiotherapy 5 days a week for 2 weeks.
- Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks
followed by boost radiotherapy 5 days a week for 1.6 weeks.
Patients with biopsy-proven persistent disease at least 6 weeks after completion of
radiotherapy undergo salvage surgery with neck dissection (at the discretion of the
surgeon).
Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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