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Trial record 1 of 1 for:    robocup
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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)

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ClinicalTrials.gov Identifier: NCT04767048
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Tracking Information
First Submitted Date  ICMJE February 19, 2021
First Posted Date  ICMJE February 23, 2021
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE June 30, 2021
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
Detection of primary cancer [ Time Frame: At surgery ]
Proportion of patients with primary cancer detected with surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
tonsillectomy +/- bilateral mucosectomy
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cancer of Head and Neck
  • Adenopathy
Intervention  ICMJE
  • Procedure: bilateral mucosectomy + tonsillectomy
    Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
  • Procedure: tonsillectomy
    tonsillectomy (unilateral or bilateral at the choice of the investigator)
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
    Intervention: Procedure: bilateral mucosectomy + tonsillectomy
  • Active Comparator: Control Arm
    Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)
    Intervention: Procedure: tonsillectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2021)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vianney BASTIT, MD 33231455050 v.bastit@baclesse.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04767048
Other Study ID Numbers  ICMJE 2020-A00947-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Centre Francois Baclesse
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Francois Baclesse
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Francois Baclesse
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP