Clinical trial · Observational
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
NCT04447456CI-TRIAL-00109082VO QualcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glottic Carcinoma | Glottis Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Surgery
- label
- Radiotherapy
Primary outcomes (1)
- measure
- Voice Handicap Index
- timeFrame
- At 5 years
- description
- 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 outcomes (3)
- measure
- Maximum Phonation Time
- timeFrame
- At 5 years
- description
- The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (1)
- RESULTLouison 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. PMID 39122636