Squamous Cell CarcinomaTORPHYNXNCT04224389
IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
An observational study of Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 16 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- transoral resection and IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 16 sitesFrance
- Study dates
- 22 Jun 2018to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Centre Hospitalier InterCommunal
Créteil, 94000
Centre Oscar Lambret
Lille, 59000
Hôpital la Croix Rousse
Lyon, 69004
Centre Léon Bérard
Lyon, 69008
CHU Conception
Marseille, 13005
CHU Montpellier
Montpellier, 34090
CHU Nantes - Hôtel Dieu
Nantes, 44000
Institut Universitaire de la face et du cou
Nice, 06100
Hôpital Européen Georges Pompidou
Paris, 75015
CHU Reims
Reims, 51100
Hôpital Charles Nicolle
Rouen, 76000
CHU Hôpital de Hautepierre
Strasbourg, 67200
Institut Claudius Regaud
Toulouse, 31100
CHU Tours
Tours, 37000
CHRU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500
Gustave Roussy
Villejuif, Val de Marne, 94800
About this study
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
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.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- transoral resection, IMRT
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral resectionProcedure or surgery
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.
IMRTRadiation
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary Receives: Radiation: IMRT | |
| Surgery | transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity Receives: Procedure: transoral resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MD Anderson Dysphagia Inventory (MDADI) global score
Score goes from 20 to 100. A higher score means a better ability to swallow
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start22 Jun 2018
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224389
- Sponsor's protocol ID
- 2017-A02253-50
- Other IDs
- 2017/2617
- Acronym
- TORPHYNX
- Status last verified
- Nov 2026
- First submitted
- 8 Jan 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04224389
- Acronym / sponsor ID
- TORPHYNX / 2017-A02253-50
- Conditions
- Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | – | Radiation: IMRTIMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary |
| Surgery | – | Procedure: transoral resectiontransoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transoral resectionThe 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. | Procedure or surgery | Surgery |
| IMRTIntensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask | Radiation | Radiotherapy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Dysphagia Inventory (MDADI) global score (time frame: 2 years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.