NCT03548285

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.

Detailed description

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)

Conditions

• Glottic Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)

Timeline

• Start date: 2018-05-15
• Primary completion: 2023-04-25
• Completion: 2024-04-30
• First posted: 2018-06-07
• Last updated: 2025-05-22
• Results posted: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study