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

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

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Key information

Conditions

Cancer of Head and Neck Adenopathy Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphadenopathy Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU CAEN, Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral mucosectomy + tonsillectomy

Procedure

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

Tonsillectomy

Procedure

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

Primary outcomes

Detection of primary cancer

Time frame: At surgery

Proportion of patients with primary cancer detected with surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Vianney BASTIT, MD

CONTACT

[email protected]

33231455050

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study 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

Acronym: RoboCUP

Important dates

Study start: 2021
Primary completion: 2029
Study completion: 2029
First posted: Feb 23, 2021
Registry last updated: Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting