Clinical Trial: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Fraction [ Time Frame: 90 days ]

To determine the feasibility of fraction reduction for early-stage laryngeal cancer without exceeding the maximum tolerated dose.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • overall survival [ Time Frame: 5 years ]
    To determine overall survival at 5 years
  • loco-regional control [ Time Frame: 5 years ]
    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.
  • functional voice quality [ Time Frame: 18 months ]
    To characterize functional voice quality of patients treated on this protocol.
  • Quality of Life [ Time Frame: 18 months ]
    To characterize the HR-QoL and PRO of patients treated on this protocol.
  • cost-effectiveness [ Time Frame: 18 months ]
    To determine cost-effectiveness of hypofractionated larynx irradiation
  • late toxicity [ Time Frame: 18 months ]
    To determine late toxicity as defined as treatment-related toxicity occurring ≥ 18 months from completion of radiation therapy.


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: November 7, 2013
Date Started: November 2013
Date Completion: December 2018
Last Updated: February 23, 2017
Last Verified: February 2017