Informations générales (source: ClinicalTrials.gov)
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study (RoboCUP)
Interventional
Phase 2
Centre Francois Baclesse (Voir sur ClinicalTrials)
juin 2021
mars 2029
17 octobre 2024
We are proposing a randomized phase II study to assess the benefit of bilateral
robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the
assessment of prevalent cervical lymphadenopathy
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre François Baclesse - Caen - France | LASNE CARDON Audrey, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - Lille - France | Samia BOUHIR, MD | Contact (sur clinicalTrials) | |||
| Chru Lille - Lille - France | Francois Mouawad, MD | Contact (sur clinicalTrials) | |||
| CHU CAEN - Caen - France | Maxime HUMBERT, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen - Rouen - France | Sophie DENEUVE, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient with a prevalent head and neck lymphadenopathy with positive or
non-contributory fine needle aspiration, or having had an adenectomy revealing a
metastasis of squamous cell carcinoma, a PET examination, an injected
cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
- Performance Status < 2
- Patient aged 18 or over
- Patient affiliated with social security system
- Informed consent signed
- Patient with a prevalent head and neck lymphadenopathy with positive or
non-contributory fine needle aspiration, or having had an adenectomy revealing a
metastasis of squamous cell carcinoma, a PET examination, an injected
cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
- Performance Status < 2
- Patient aged 18 or over
- Patient affiliated with social security system
- Informed consent signed
- History of squamous cell carcinoma of the VADS or skin of the face.
- History of cervico-facial radiotherapy
- Primary tumor discovering during pan-endoscopy
- Inexposable patient lead not to possible mucosectomy
- Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic
bilateral mucosectomy of language)
- Distant metastases
- Lymphadenopathy inoperable
- Patient with a contraindication to radiotherapy
- Pregnant or breastfeeding woman
- Women of childbearing potential without effective contraception
- Patient under guardianship or unable to give informed consent
- Patient unable to undergo the trial follow-up for geographic, social or
psychopathological reasons