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

Primary Purpose

Cancer of Head and Neck, Adenopathy

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bilateral mucosectomy + tonsillectomy
tonsillectomy
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer of Head and Neck focused on measuring mucosectomy, tonsil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François BaclesseRecruiting
  • CHU CAENRecruiting
  • Centre Oscar LambretRecruiting
  • Chru LilleRecruiting
  • CHU RouenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Control Arm

Arm Description

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

Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)

Outcomes

Primary Outcome Measures

Detection of primary cancer
Proportion of patients with primary cancer detected with surgery

Secondary Outcome Measures

Full Information

First Posted
February 19, 2021
Last Updated
March 9, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04767048
Brief Title
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck, Adenopathy
Keywords
mucosectomy, tonsil

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
tonsillectomy +/- bilateral mucosectomy
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)
Intervention Type
Procedure
Intervention Name(s)
bilateral mucosectomy + tonsillectomy
Intervention Description
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Intervention Description
tonsillectomy (unilateral or bilateral at the choice of the investigator)
Primary Outcome Measure Information:
Title
Detection of primary cancer
Description
Proportion of patients with primary cancer detected with surgery
Time Frame
At surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vianney BASTIT, MD
Phone
33231455050
Email
v.bastit@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vianney BASTIT, MD
Email
v.bastit@baclesse.unicancer.fr
Facility Name
CHU CAEN
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime HUMBERT, MD
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samia BOUHIR, MD
Facility Name
Chru Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Mouawad, MD
Facility Name
CHU Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DENEUVE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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