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Clinical Trials in France / NCT04767048
Recruiting Phase 2

Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy

NCT04767048 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2021-06-30
Last updated
2024-10-15

Condition(s) studied

Cancer of Head and NeckAdenopathy

Investigational drug(s) / intervention(s)

bilateral mucosectomy + tonsillectomytonsillectomy

bilateral mucosectomy + tonsillectomy: Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

tonsillectomy: tonsillectomy (unilateral or bilateral at the choice of the investigator)

Study 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 cervical lymphadenopathy

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Centre François Baclesse Caen France Recruiting
CHU CAEN Caen France Recruiting
Centre Oscar Lambret Lille France Recruiting
Chru Lille Lille France Recruiting
CHU Rouen Rouen France Recruiting

More Centre Francois Baclesse trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04767048 on ClinicalTrials.gov ↗ ← All trials in France