Clinical trial NCT04224389: IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
Official title: Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who have been treated with IMRT and those who were treated by transoral surgery for a carcinoma squamous cell of the early stage oropharynx

Brief 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 criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. ECOG performance status 0-2
3. Histologically confirmed squamous cell carcinoma
4. Primitive localization of the oropharynx on the tonsil compartment or the tongue base
5. p16 or HPV status available
6. TNM classification AJCC7th T1 or T2
7. TNM classification AJCC7th N0 or N1
8. Patient and tumor that can be treated by radiotherapy or by transoral surgery
9. 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

Exclusion Criteria:

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

Primary outcomes:
measure: MD Anderson Dysphagia Inventory (MDADI) global score
timeFrame: 2 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
city: Créteil
country: France
facility: Centre Hospitalier InterCommunal
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Hôpital la Croix Rousse
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: CHU Conception
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
city: Nice
country: France
facility: Institut Universitaire de la face et du cou
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Reims
country: France
facility: CHU Reims
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHU Hôpital de Hautepierre
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: CHU Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy - Hôpital de Brabois
Study officials:
References: