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NCT04767048 Clinical Trial

Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy

Cancer of Head and Neck Clinical Trial

— RoboCUP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04767048
Other study ID # 2020-A00947-32
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2021
Est. completion date March 2029

Study information
Verified date May 2024
Source Centre Francois Baclesse
Contact Vianney BASTIT, MD
Phone 33231455050
Email v.bastit@baclesse.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date March 2029
Est. primary completion date March 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• bilateral mucosectomy + tonsillectomy
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
• tonsillectomy
tonsillectomy (unilateral or bilateral at the choice of the investigator)

Locations
Country Name City State
France Centre François Baclesse Caen
France CHU CAEN Caen
France Centre Oscar Lambret Lille
France Chru Lille Lille
France CHU Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of primary cancer Proportion of patients with primary cancer detected with surgery At surgery
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