This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT) in combination with our standard chemotherapy program for patients with stage 3-4 squamous cell carcinoma of the larynx. The primary hypothesis of our study is that the study program will improve Laryngectomy-Free Survival compared to historical controls. The study is limited to patients who would be receiving primary RT-C as standard therapy off-study.
The novel radiotherapy schedule that is the subject of this study is only slightly different from the program that has been used in the cooperative group trial RTOG 9003. The radiation therapy dose schedule in our study twice-daily alternating fractions over 30 treatment days. The Biologically Effective Dose (BED) of this schedule is about 11% higher than our standard schedule twice-a-day. During radiotherapy, patients will receive chemotherapy with our standard program of weekly.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Increased radiation therapy dose
Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician
University of Florida
Gainesville, Florida, United States
Whether radiation therapy dose escalation as used in our study will improve Laryngectomy-Free Survival compared to historical controls in patients with locally advanced squamous cell carcinoma of the larynx.
Patients will receive an increased dose of radiation therapy
Time frame: Up to 2 years
Patient reported quality of life
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients Likert scales 1-4,(1 = All, 2 = Little, 3 = a Bit, 4 = Very much)
Time frame: Up to 2 years
Psychosocial function
Voice Handicap Index (VHI) a 30-item questionnaire. Likert scale 0- 4, 0 = never and 4 Always) A change between two administrations of 18 points represents a significant shift in psychosocial function.
Time frame: Up to 2 years
Swallowing ability.
The MD Anderson Symptom Inventory (MDASI) is a multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms.MD Anderson Dysphagia Index (MDADI)
Time frame: Up to 2 years
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