Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy (RoboCUP)

October 10, 2024 updated by: Centre Francois Baclesse

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
      • Caen, France
        • Recruiting
        • CHU caen
        • Contact:
          • Maxime HUMBERT, MD
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Samia BOUHIR, MD
      • Lille, France
        • Recruiting
        • CHRU Lille
        • Contact:
          • François MOUAWAD, MD
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Sophie DENEUVE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
Procedure: bilateral mucosectomy + tonsillectomy
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
Active Comparator: Control Arm
Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)
Procedure: tonsillectomy
tonsillectomy (unilateral or bilateral at the choice of the investigator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of primary cancer
Time Frame: At surgery
Proportion of patients with primary cancer detected with surgery
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00947-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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