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

May 7, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Créteil, France, 94000
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
          • Héloïse DE KERMADEC, MD
      • Lille, France, 59000
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Sophie DENEUVE, MD
      • Lyon, France, 69004
      • Marseille, France, 13005
      • Montpellier, France, 34090
      • Nantes, France, 44000
      • Nice, France, 06100
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Haitham MIRGHANI, MD
      • Reims, France, 51100
        • Recruiting
        • CHU Reims
        • Contact:
          • Esteban BRENET, MD
      • Rouen, France, 76000
      • Strasbourg, France, 67200
      • Toulouse, France, 31100
      • Tours, France, 37000
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • CHRU Nancy - Hôpital de Brabois
        • Contact:
          • Romina MASTRONICOLA, MD
    • Val De Marne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. ECOG performance status 0-2
  3. Histologically confirmed squamous cell carcinoma
  4. Primitive localization of the oropharynx on the tonsil compartment or the tongue base
  5. p16 or HPV status available
  6. TNM classification AJCC7th T1 or T2
  7. TNM classification AJCC7th N0 or N1
  8. Patient and tumor that can be treated by radiotherapy or by transoral surgery
  9. 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:

  1. Severe medical comorbidity or other contraindication to radiotherapy or surgery
  2. Primary tumor or unresectable lymphadenopathy
  3. Metastatic disease
  4. History of squamous cell carcinoma of the head and neck within 5 years
  5. History of radiation therapy to the head and neck
  6. Inability to undergo or complete radiation therapy follow-up consultations
  7. History of cancer except free of any disease for at least 5 years, with the exception of non-melanoma skin cancers
  8. Inability to complete questionnaires
  9. Pregnant or lactating woman
  10. Patient under tutorship or curatorship, deprived of liberty or unable to do so to express consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2018

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02253-50
  • 2017/2617 (Other Identifier: CSET number (Gustave Roussy ID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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