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

Squamous Cell Carcinoma Clinical Trial

— TORPHYNX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224389
• Other study ID #: 2017-A02253-50
• Secondary ID: 2017/2617
• Status: Recruiting
• Start date: June 22, 2018
• Est. completion date: June 2026

Study information

• Verified date: February 2020
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Philippe Gorphe, MD
• Phone: 0142114211
• Email: philippe.gorphe[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 oropharynx.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

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.

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

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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