Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    robocup
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Adenopathy Procedure: bilateral mucosectomy + tonsillectomy Procedure: tonsillectomy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: tonsillectomy +/- bilateral mucosectomy
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

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)




Primary Outcome Measures :
  1. Detection of primary cancer [ Time Frame: At surgery ]
    Proportion of patients with primary cancer detected with surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767048


Contacts
Layout table for location contacts
Contact: Vianney BASTIT, MD 33231455050 v.bastit@baclesse.unicancer.fr

Locations
Layout table for location information
France
Centre François Baclesse Recruiting
Caen, France
Contact: Vianney BASTIT, MD       v.bastit@baclesse.unicancer.fr   
Sponsors and Collaborators
Centre Francois Baclesse
Layout table for additonal information
Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT04767048    
Other Study ID Numbers: 2020-A00947-32
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
mucosectomy
tonsil
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Lymphadenopathy
Lymphatic Diseases
Neoplasms by Site
Neoplasms