Assessing tongue and tonsil surgery for head and neck cancer lymphadenopathy
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study
This study is testing if a new type of surgery on the tongue and tonsils can help doctors better understand and treat lymph node issues in patients with head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Locations | 5 sites (Caen and 4 other locations) |
| Trial ID | NCT04767048 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with prevalent head and neck lymphadenopathy and no identifiable primary tumor.
Not a fit: Patients with a history of squamous cell carcinoma in the head and neck region or those with inoperable lymphadenopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the diagnostic accuracy and treatment outcomes for patients with head and neck cancer.
How similar studies have performed: While similar surgical approaches have been explored, this specific combination of interventions is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Caen and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.