๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
Exclusion Criteria:
* 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
๐
What it tests
- bilateral mucosectomy + tonsillectomy
- tonsillectomy
Centre Franรงois Baclesse
Caen, France
CHU CAEN
Caen, France
Centre Oscar Lambret
Lille, France
Chru Lille
Lille, France
CHU Rouen
Rouen, France
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.