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

Gustave Roussy

Status: Enrolling

Conditions: Squamous Cell Carcinoma

Treatments: Procedure: transoral resection; Radiation: IMRT

Study type: Observational

Funder types: Other

Identifiers

NCT04224389

2017/2617 (Other Identifier)

2017-A02253-50

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Radiotherapy

Description:

IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary

Treatment:

Radiation: IMRT

Surgery

Description:

transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity

Treatment:

Procedure: transoral resection