Clinical trial · Interventional
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical 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
NCT04767048CI-TRIAL-00081603RoboCUPrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenopathy | — | UNRESOLVED | — |
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bilateral mucosectomy + tonsillectomy | Procedure | — | UNRESOLVED |
| tonsillectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
- interventionNames
- Procedure: bilateral mucosectomy + tonsillectomy
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)
- interventionNames
- Procedure: tonsillectomy
Primary outcomes (1)
- measure
- Detection of primary cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBastit 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/s12885-025-13913-7. PMID 40148848