Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Recruiting now · Phase 2
Conditions studied: Cancer of Head and Neck, Adenopathy
In brief
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
Key facts
- Study ID
- NCT04767048
- Run by
- Centre Francois Baclesse
- People needed
- 72
- Starts
- 2021-06-30
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2024-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Centre François Baclesse — Caen, France (enrolling)
- CHU CAEN — Caen, France (enrolling)
- Centre Oscar Lambret — Lille, France (enrolling)
- Chru Lille — Lille, France (enrolling)
- CHU Rouen — Rouen, France (enrolling)
Full record on ClinicalTrials.gov
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