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Brief Title: Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Official Title: A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Study ID: NCT03759431
Brief Summary: This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
London Health Sciences Centre, London, Ontario, Canada
Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada
Name: Houda Bahig
Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
Role: STUDY_CHAIR
Name: David Palma
Affiliation: London Health Sciences Centre
Role: STUDY_CHAIR