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

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Recruiting

CT.gov ID

NCT04767048

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

14.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 30, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Detection of primary cancer [At surgery]
Proportion of patients with primary cancer detected with surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Centre François Baclesse	Caen	France
2	CHU CAEN	Caen	France
3	Centre Oscar Lambret	Lille	France
4	Chru Lille	Lille	France
5	CHU Rouen	Rouen	France

Sponsors and Collaborators

Centre Francois Baclesse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT04767048

Other Study ID Numbers:

2020-A00947-32

First Posted:

Feb 23, 2021

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Francois Baclesse

mucosectomy

tonsil

Additional relevant MeSH terms:

Head and Neck Neoplasms

Lymphadenopathy

Study Results

No Results Posted as of Jul 14, 2022