This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.
SBRT treatment will be delivered to patients diagnosed with stage I-II glottic larynx cancer twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk). Low-risk is defined by: * Planning target volume (PTV) less than 10 cc, AND * No reported smoking within 1 month from registration Moderate-risk is defined by: * Planning target volume (PTV) greater than or equal to 10 cc, OR * Smoking within 1 month from registration (no more than 1 pack per day)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
Time frame: 2 years
Voice-quality Score Following Treatment With SABR
Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment. 0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap
Time frame: From baseline to 2 years post-treatment
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR
Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.
Time frame: 90 days, 3 years
Health-related Quality of Life Following Treatment With SABR.
Average patient visual analogue scale score (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment The Visual Analogue Score (VAS) of the EQ-5D is a visual scale from 0-100, with 100 being perfect health, where patients can mark their perceived health. Researchers can then take the average score across all patients for each timepoint.
Time frame: From baseline to 2 years post-treatment
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk
Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.
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Time frame: 2 years
Overall Survival
Overall survival
Time frame: 2 years
Percentage of Patient Population With Regional Failure and Distant Metastasis
With death and prior locoregional failure as competing risks
Time frame: 2 years
Laryngectomy-free Survival
Laryngectomy-free survival probability at 2 years
Time frame: 2 years