Assessing tongue and tonsil surgery for head and neck cancer lymphadenopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial aims to evaluate the effectiveness of bilateral robot-assisted or laser basal tongue mucosectomy combined with tonsillectomy in patients with prevalent cervical lymphadenopathy. Participants will be randomized to receive one of the surgical interventions to determine their impact on assessing lymphadenopathy related to head and neck cancer. The study focuses on patients who have undergone preliminary examinations that did not reveal a primary tumor. The goal is to improve diagnostic and treatment strategies for patients with head and neck cancers.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Vianney BASTIT, MD
• Email: v.bastit@baclesse.unicancer.fr
• Phone: 33231455050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.