NCT04767048RecruitingPhase 2
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 19 Feb 2021
- Start date
- 30 Jun 2021
- Primary completion date
- Mar 2029
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Head and neck cancer
- NCT number
- NCT04767048
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 72
- From 30 Jun 2021 to the primary completion date, Mar 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with a contraindication to radiotherapy
Other illness
- History of squamous cell carcinoma of the VADS or skin of the face.
- History of cervico-facial radiotherapy
- Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
Other
- Primary tumor discovering during pan-endoscopy
- Inexposable patient lead not to possible mucosectomy
- Distant metastases
- Lymphadenopathy inoperable
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.