RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy and laser surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx.
OBJECTIVES: I. Assess the feasibility of treating untreated stage I, II and selected stage III squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and irradiation. II. Estimate the 3 year progression free survival and describe the location of disease progression. OUTLINE: Patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration. Patients with N1 disease may undergo an optional neck dissection ipsilateral to the neck mass. Neck dissection includes complete removal of at least lymph node levels 2-4. Radiation therapy begins 14 days following laser surgery. Patients are followed every 3 months for the first year, every 6 months for the second year, and every 12 months thereafter until death. PROJECTED ACCRUAL: There will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed
200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of California Davis Medical Center
feasibility
To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).
Time frame: 4 years
progression-free survival
From date of registration to date of first observation of progressive disease, death due to any cause or early discontinuation of treatment
Time frame: 3 years
return to swallowing function
how long patients require feeding tubes and the proportion of patients requiring tracheostomy
Time frame: two weeks
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