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Spots Global Cancer Trial Database for Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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