Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

Completed

• Conditions: Glottic Carcinoma

• Registration Number: NCT04447456
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-11-03
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voice Handicap Index	At 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)	At 5 years	This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability.; A high score is associated with a voice perceived as bad by the audience.
Acoustic Analysis by Vocalab software	At 5 years	short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.
Maximum Phonation Time	At 5 years	The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.

Trial Locations

Locations (2)

Centre Oscar Lambret; 🇫🇷 Lille, France

Hôpital Huriez, CHU; 🇫🇷 Lille, France