NCT04767048

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
34mo left

Started Jun 2021

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jun 2021Mar 2029

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

7.7 years

First QC Date

February 19, 2021

Last Update Submit

October 10, 2024

Conditions

Cancer of Head and NeckAdenopathy

Keywords

mucosectomytonsil

Outcome Measures

Primary Outcomes (1)

  • Detection of primary cancer

    Proportion of patients with primary cancer detected with surgery

    At surgery

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Procedure: bilateral mucosectomy + tonsillectomy

Control Arm

ACTIVE COMPARATOR

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

Procedure: tonsillectomy

Interventions

bilateral mucosectomy + tonsillectomyPROCEDURE

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

Experimental Arm
tonsillectomyPROCEDURE

tonsillectomy (unilateral or bilateral at the choice of the investigator)

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre François Baclesse

Caen, France

RECRUITING

CHU CAEN

Caen, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Chru Lille

Lille, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

Related Publications (1)

  • Bastit V, Lequesne J, Leconte A, Deneuve S, Mouawad F, Quak E, Jeanne C, Clarisse B, Thariat J. Effectiveness of bilateral tongue base mucosectomy by transoral robotic surgery or transoral laser microsurgery in combination with tonsillectomy in identifying head and neck primary cancer of unknown primary: a randomized phase 2 protocol (RoboCUP trial). BMC Cancer. 2025 Mar 27;25(1):551. doi: 10.1186/s12885-025-13913-7.

    PMID: 40148848DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphadenopathy

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Vianney BASTIT, MD

CONTACT

33231455050v.bastit@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
tonsillectomy +/- bilateral mucosectomy
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

June 30, 2021

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)