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

See Contacts and Locations

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

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

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

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

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:

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

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