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Recruiting Observational

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

NCT04224389 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2018-06-22
Last updated
2025-05-08

Condition(s) studied

Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

transoral resectionIMRT

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • MD Anderson Dysphagia Inventory (MDADI) global score — 2 years after inclusion
    Score goes from 20 to 100. A higher score means a better ability to swallow

Trial sites (16)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04224389 on ClinicalTrials.gov ↗ ← All trials in France