NCT04224389

IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas

Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	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.
RADIATION	IMRT	Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask

Timeline

• Start date: 2018-06-22
• Primary completion: 2031-06-01
• Completion: 2031-06-01
• First posted: 2020-01-13
• Last updated: 2025-05-08

Locations

16 sites across 1 country: France