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

Phase 2

Recruiting

• Conditions: Adenopathy; Cancer of Head and Neck
• Interventions: Procedure: tonsillectomy; Procedure: bilateral mucosectomy + tonsillectomy

• Registration Number: NCT04767048
• Lead Sponsor: Centre Francois Baclesse

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 cervical lymphadenopathy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	tonsillectomy	Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)
Experimental Arm	bilateral mucosectomy + tonsillectomy	Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

Primary Outcome Measures

Name	Time	Method
Detection of primary cancer	At surgery	Proportion of patients with primary cancer detected with surgery

Trial Locations

Locations (5)

Centre François Baclesse; 🇫🇷 Caen, France

CHU CAEN; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Chru Lille; 🇫🇷 Lille, France

CHU Rouen; 🇫🇷 Rouen, France