Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
VO Qual
2 other identifiers
observational
41
1 country
2
Brief Summary
Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2022
CompletedApril 22, 2026
February 1, 2023
1.2 years
June 22, 2020
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Voice Handicap Index
The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient.
At 5 years
Secondary Outcomes (3)
Maximum Phonation Time
At 5 years
Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
At 5 years
Acoustic Analysis by Vocalab software
At 5 years
Study Arms (2)
Surgery
Radiotherapy
Eligibility Criteria
patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
You may qualify if:
- Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery.
- patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
- Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Oscar Lambret
Lille, 59000, France
Hôpital Huriez, CHU
Lille, France
Related Publications (1)
Louison J, Labreuche J, Liem X, Rysman B, Morisse M, Mortuaire G, Mouawad F. Voice quality after surgery or radiotherapy for glottic T1 squamous cell carcinoma: Results of the VOQUAL study. Cancer Radiother. 2024 Aug;28(4):373-379. doi: 10.1016/j.canrad.2024.03.004. Epub 2024 Aug 9. Erratum In: Cancer Radiother. 2024 Dec;28(8):727. doi: 10.1016/j.canrad.2024.09.001.
PMID: 39122636RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
François Mouawad, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 25, 2020
Study Start
November 3, 2020
Primary Completion
January 19, 2022
Study Completion
January 19, 2022
Last Updated
April 22, 2026
Record last verified: 2023-02