The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose fraction reduction study.
Patients enrolled at each dose level will undergo routine evaluations to identify potential toxicities as well functional voice analyses. Adequate waiting periods will be used to ensure that fraction reduction does not proceed prior to observing toxicity. The purpose of the study will be either to determine the maximal fraction reduction possible until a dose is reached where a dose-limiting toxicity occurs. The initial dose and fractionation will be 50 Gy in 15 fractions with the goal to reduce number of fractions to a dose of 42.5 Gy in 5 fractions. The rationale for using 5 fractions is that it is tolerated in centrally located lung tumors at a dose of 50 Gy in 5 fractions, and thus, is likely to be tolerated in large calliber airways.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
Fraction
To determine the feasibility of fraction reduction for early-stage laryngeal cancer without exceeding the maximum tolerated dose.
Time frame: 90 days
overall survival
To determine overall survival at 5 years
Time frame: 5 years
loco-regional control
To determine loco-regional control at 5 years as determined by physical exam, visualization of tumor by layngoscopy, and CT-scan of the neck to determine if the primary tumor is controlled. A tissue biopsy or recurrent or persistent disease will be required to be considered a loco-regional failure.
Time frame: 5 years
functional voice quality
To characterize functional voice quality of patients treated on this protocol.
Time frame: 18 months
Quality of Life
To characterize the HR-QoL and PRO of patients treated on this protocol.
Time frame: 18 months
cost-effectiveness
To determine cost-effectiveness of hypofractionated larynx irradiation
Time frame: 18 months
late toxicity
To determine late toxicity as defined as treatment-related toxicity occurring ≥ 18 months from completion of radiation therapy.
Time frame: 18 months
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