IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
TORPHYNX
Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
2 other identifiers
observational
150
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2018
CompletedFirst Submitted
Initial submission to the registry
January 8, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
May 8, 2025
May 1, 2025
13 years
January 8, 2020
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Radiotherapy
IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary
Surgery
transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
Interventions
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.
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Eligibility Criteria
patients who have been treated with IMRT and those who were treated by transoral surgery for a carcinoma squamous cell of the early stage oropharynx
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Gustave Roussy
Villejuif, Val De Marne, 94800, France
Centre Hospitalier InterCommunal
Créteil, 94000, France
Centre Oscar Lambret
Lille, 59000, France
Hôpital la Croix Rousse
Lyon, 69004, France
Centre Léon Bérard
Lyon, 69008, France
CHU Conception
Marseille, 13005, France
CHU Montpellier
Montpellier, 34090, France
CHU Nantes - Hôtel Dieu
Nantes, 44000, France
Institut Universitaire de la face et du cou
Nice, 06100, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
CHU Reims
Reims, 51100, France
Hôpital Charles Nicolle
Rouen, 76000, France
CHU Hôpital de Hautepierre
Strasbourg, 67200, France
Institut Claudius Regaud
Toulouse, 31100, France
CHU Tours
Tours, 37000, France
CHRU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2020
First Posted
January 13, 2020
Study Start
June 22, 2018
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share