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

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.

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gustave Roussy, Villejuif, Val De Marne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transoral resection

Procedure

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

Radiation

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

Primary outcomes

MD Anderson Dysphagia Inventory (MDADI) global score

Time frame: 2 years after inclusion

Score goes from 20 to 100. A higher score means a better ability to swallow

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Gorphe, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Thibaud Motreff

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: TORPHYNX

Important dates

Study start: 2018
Primary completion: 2031
Study completion: 2031
First posted: Jan 13, 2020
Registry last updated: May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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