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

Recruiting now

Conditions studied: Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04224389

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

150

Starts

2018-06-22

Expected to finish

2031-06-01

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• ECOG performance status 0-2
• Histologically confirmed squamous cell carcinoma
• Primitive localization of the oropharynx on the tonsil compartment or the tongue base
• p16 or HPV status available
• TNM classification AJCC7th T1 or T2
• TNM classification AJCC7th N0 or N1
• Patient and tumor that can be treated by radiotherapy or by transoral surgery
• Patient who has not objected to participate after being informed about the study. The patient must be able and willing to cooperate in follow-up and study visits

You may not qualify if…

• Severe medical comorbidity or other contraindication to radiotherapy or surgery
• Primary tumor or unresectable lymphadenopathy
• Metastatic disease
• History of squamous cell carcinoma of the head and neck within 5 years
• History of radiation therapy to the head and neck
• Inability to undergo or complete radiation therapy follow-up consultations
• History of cancer except free of any disease for at least 5 years, with the exception of non-melanoma skin cancers
• Inability to complete questionnaires
• Pregnant or lactating woman
• Patient under tutorship or curatorship, deprived of liberty or unable to do so to express consent

Where it is running

• Gustave Roussy — Villejuif, Val De Marne, France (enrolling)
• Centre Hospitalier InterCommunal — Créteil, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• Hôpital la Croix Rousse — Lyon, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• CHU Conception — Marseille, France (enrolling)
• CHU Montpellier — Montpellier, France (enrolling)
• CHU Nantes - Hôtel Dieu — Nantes, France (enrolling)
• Institut Universitaire de la face et du cou — Nice, France (enrolling)
• Hôpital Européen Georges Pompidou — Paris, France (enrolling)
• CHU Reims — Reims, France (enrolling)
• Hôpital Charles Nicolle — Rouen, France (enrolling)
• CHU Hôpital de Hautepierre — Strasbourg, France (enrolling)
• Institut Claudius Regaud — Toulouse, France (enrolling)
• CHU Tours — Tours, France (enrolling)
• CHRU Nancy - Hôpital de Brabois — Vandœuvre-lès-Nancy, France (enrolling)

Full record on ClinicalTrials.gov

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