Status:
RECRUITING
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Cancer of Head and Neck
Adenopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cervic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04767048
Start Date
June 30 2021
End Date
March 1 2029
Last Update
October 15 2024
Active Locations (5)
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1
Centre François Baclesse
Caen, France
2
CHU CAEN
Caen, France
3
Centre Oscar Lambret
Lille, France
4
Chru Lille
Lille, France