Actively Recruiting

Age: 18Years +
All Genders
NCT04224389

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

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-05-08

150

Participants Needed

16

Research Sites

675 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status between 0 and 2
  • Histologically confirmed squamous cell carcinoma
  • Tumor located in the tonsil compartment or base of the tongue in the oropharynx
  • Available p16 or HPV status
  • Tumor stage T1 or T2 according to AJCC7th
  • Lymph node stage N0 or N1 according to AJCC7th
  • Tumor and patient suitable for radiotherapy or transoral surgery
  • Patient has given informed consent and is willing to cooperate with follow-up and study visits
Not Eligible

You will not qualify if you...

  • Severe medical condition or contraindications to radiotherapy or surgery
  • Unresectable primary tumor or lymphadenopathy
  • Presence of metastatic disease
  • History of head and neck squamous cell carcinoma within the past 5 years
  • Previous radiation therapy to the head and neck
  • Unable to undergo or complete radiation therapy follow-up
  • History of cancer within 5 years except non-melanoma skin cancers
  • Unable to complete study questionnaires
  • Pregnant or breastfeeding women
  • Patients under legal guardianship, deprived of liberty, or unable to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Gustave Roussy

Villejuif, Val De Marne, France, 94800

Actively Recruiting

2

Centre Hospitalier InterCommunal

Créteil, France, 94000

Actively Recruiting

3

Centre Oscar Lambret

Lille, France, 59000

Actively Recruiting

4

Hôpital la Croix Rousse

Lyon, France, 69004

Actively Recruiting

5

Centre Léon Bérard

Lyon, France, 69008

Actively Recruiting

6

CHU Conception

Marseille, France, 13005

Actively Recruiting

7

CHU Montpellier

Montpellier, France, 34090

Actively Recruiting

8

CHU Nantes - Hôtel Dieu

Nantes, France, 44000

Actively Recruiting

9

Institut Universitaire de la face et du cou

Nice, France, 06100

Actively Recruiting

10

Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

11

CHU Reims

Reims, France, 51100

Actively Recruiting

12

Hôpital Charles Nicolle

Rouen, France, 76000

Actively Recruiting

13

CHU Hôpital de Hautepierre

Strasbourg, France, 67200

Actively Recruiting

14

Institut Claudius Regaud

Toulouse, France, 31100

Actively Recruiting

15

CHU Tours

Tours, France, 37000

Actively Recruiting

16

CHRU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

P

Philippe Gorphe, MD

CONTACT

T

Thibaud Motreff

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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