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

• 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

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