Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bilateral mucosectomy + tonsillectomy, tonsillectomy.
- Who it may be relevant to
- Registry conditions: Cancer of Head and Neck, Adenopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Procedure bilateral mucosectomy + tonsillectomy
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) - Procedure tonsillectomy
tonsillectomy (unilateral or bilateral at the choice of the investigator)
Primary outcome measures
- Detection of primary cancer [Time frame: At surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 5 centers
- Centre François Baclesse — Caen
- CHU CAEN — Caen
- Centre Oscar Lambret — Lille
- Chru Lille — Lille
- CHU Rouen — Rouen
Publications
- Bastit V, Lequesne J, Leconte A, Deneuve S, Mouawad F, Quak E, Jeanne C, Clarisse B, Thariat J. Effectiveness of bilateral tongue base mucosectomy by transoral robotic surgery or transoral laser microsurgery in combination with tonsillectomy in identifying head and neck primary cancer of unknown primary: a randomized phase 2 protocol (RoboCUP trial). BMC Cancer. 2025 Mar 27;25(1):551. doi: 10.1186 PMID 40148848
Identifiers
NCT: NCT04767048 · 2020-A00947-32