RecruitingNCT04224389

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

150 participants

Start Date

Jun 22, 2018

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing radiation therapy to surgery (performed through the mouth) for early-stage squamous cell carcinoma of the tonsil area or base of the tongue (throat cancer), looking at which approach leads to better outcomes and quality of life. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the tonsil or base of the tongue (throat cancer) - Your tumor is an early stage (T1 or T2) and has not spread widely to lymph nodes (N0 or N1) - You can be treated with either surgery or radiation - Your HPV/p16 status has been assessed **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had prior radiation to your head or neck - You have had a squamous cell carcinoma of the head and neck in the last 5 years - Your cancer is not surgically removable - You are pregnant or breastfeeding - You are unable to complete questionnaires or follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREtransoral 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.

RADIATIONIMRT

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


Locations(16)

Gustave Roussy

Villejuif, Val De Marne, France

Centre Hospitalier InterCommunal

Créteil, France

Centre Oscar Lambret

Lille, France

Hôpital la Croix Rousse

Lyon, France

Centre Léon Bérard

Lyon, France

CHU Conception

Marseille, France

CHU Montpellier

Montpellier, France

CHU Nantes - Hôtel Dieu

Nantes, France

Institut Universitaire de la face et du cou

Nice, France

Hôpital Européen Georges Pompidou

Paris, France

CHU Reims

Reims, France

Hôpital Charles Nicolle

Rouen, France

CHU Hôpital de Hautepierre

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

CHU Tours

Tours, France

CHRU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04224389


Related Trials