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

Study Overview
=================
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.

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

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: transoral resection
* Radiation: IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiotherapy<br>IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary | Radiation: IMRT<br>* Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask<br>|
| Surgery<br>transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity | Procedure: transoral resection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MD Anderson Dysphagia Inventory (MDADI) global score | Score goes from 20 to 100. A higher score means a better ability to swallow | 2 years after inclusion |