IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transoral resection, IMRT.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure 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. - Radiation IMRT
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Primary outcome measures
- MD Anderson Dysphagia Inventory (MDADI) global score [Time frame: 2 years after inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 16 centers
- Gustave Roussy — Villejuif
- Centre Hospitalier InterCommunal — Créteil
- Centre Oscar Lambret — Lille
- Hôpital la Croix Rousse — Lyon
- Centre Léon Bérard — Lyon
- CHU Conception — Marseille
- CHU Montpellier — Montpellier
- CHU Nantes - Hôtel Dieu — Nantes
- … and 8 more centers
Identifiers
NCT: NCT04224389 · 2017-A02253-50 · 2017/2617