Actively Recruiting
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Led by Centre Francois Baclesse · Updated on 2024-10-15
72
Participants Needed
5
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 2
- Patient aged 18 or over
- Patient affiliated with social security system
- Informed consent signed
You will not qualify if you...
- History of squamous cell carcinoma of the VADS or skin of the face
- History of cervico-facial radiotherapy
- Primary tumor discovered during pan-endoscopy
- Patient not eligible for mucosectomy due to inaccessible lesion
- Uncontrollable bleeding disorders contraindicating tonsillectomy and bilateral basic mucosectomy
- Presence of distant metastases
- Lymphadenopathy that cannot be operated on
- 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 follow up due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centre François Baclesse
Caen, France
Actively Recruiting
2
CHU CAEN
Caen, France
Actively Recruiting
3
Centre Oscar Lambret
Lille, France
Actively Recruiting
4
Chru Lille
Lille, France
Actively Recruiting
5
CHU Rouen
Rouen, France
Actively Recruiting
Research Team
V
Vianney BASTIT, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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