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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) |
|
| Control Arm | Active Comparator | Tonsillectomy alone (unilateral or bilateral at the choice of the investigator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilateral mucosectomy + tonsillectomy | Procedure | Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of primary cancer | Proportion of patients with primary cancer detected with surgery | At surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vianney BASTIT, MD | Contact | 33231455050 | v.bastit@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Recruiting | Caen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40148848 | Derived | 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/s12885-025-13913-7. |
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tonsillectomy +/- bilateral mucosectomy
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| tonsillectomy | Procedure | tonsillectomy (unilateral or bilateral at the choice of the investigator) |
|
| CHU CAEN | Recruiting | Caen | France |
|
| Centre Oscar Lambret | Recruiting | Lille | France |
|
| Chru Lille | Recruiting | Lille | France |
|
| CHU Rouen | Recruiting | Rouen | France |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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