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

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: Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: IMRT; Procedure: transoral resection

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Philippe Gorphe, MD; Phone Number: +33 0142114211; Email: philippe.gorphe@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94800
      • Recruiting
      • Gustave Roussy
      • Contact: Philippe Gorphe, MD; Phone Number: +33 0142114211; Email: philippe.gorphe@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

2

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	Score goes from 20 to 100. A higher score means a better ability to swallow	2 years after inclusion

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2026

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): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: 2017-A02253-50; 2017/2617 (Other Identifier: CSET number)

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