IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
Condition(s) studied
Investigational drug(s) / intervention(s)
transoral resection: The technique of transoral surgery will be left to the choice of the surgeon according to the equipment and the experience of the team and will be gathered. The options are: transoral surgery robot-assisted, endoscopic laser transoral surgery, transoral laser surgery classical instruments. The exact description of the resected area will be collected. of the cross-sections will be made for extemporaneous analysis if necessary in lateral margins and deep until complete excision.
IMRT: Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Study summary
Compare patients' feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx.
Eligibility
Primary outcome measure(s)
- MD Anderson Dysphagia Inventory (MDADI) global score — 2 years after inclusion
Score goes from 20 to 100. A higher score means a better ability to swallow
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Gustave Roussy | Villejuif | Val De Marne | Recruiting |
| Centre Hospitalier InterCommunal | Créteil | France | Recruiting |
| Centre Oscar Lambret | Lille | France | Recruiting |
| Hôpital la Croix Rousse | Lyon | France | Recruiting |
| Centre Léon Bérard | Lyon | France | Recruiting |
| CHU Conception | Marseille | France | Recruiting |
| CHU Montpellier | Montpellier | France | Recruiting |
| CHU Nantes - Hôtel Dieu | Nantes | France | Recruiting |
| Institut Universitaire de la face et du cou | Nice | France | Recruiting |
| Hôpital Européen Georges Pompidou | Paris | France | Recruiting |
| CHU Reims | Reims | France | Recruiting |
| Hôpital Charles Nicolle | Rouen | France | Recruiting |
| CHU Hôpital de Hautepierre | Strasbourg | France | Recruiting |
| Institut Claudius Regaud | Toulouse | France | Recruiting |
| CHU Tours | Tours | France | Recruiting |
| CHRU Nancy - Hôpital de Brabois | Vandœuvre-lès-Nancy | France | Recruiting |
More Gustave Roussy, Cancer Campus, Grand Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04224389 on ClinicalTrials.gov ↗ ← All trials in France