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

Recruiting

• Conditions: Squamous Cell Carcinoma
• Interventions: Procedure: transoral resection; Radiation: IMRT

• Registration Number: NCT04224389
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-22
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2031-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	transoral resection	transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
Radiotherapy	IMRT	IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (16)

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

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France