CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 72 target
Drug / intervention
bilateral mucosectomy + tonsillectomy +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Head and neck lymphadenopathy with positive/non-contributory FNA or adenectomy-confirmed squamous cell carcinoma metastasis
  • ✓No primary tumor found on PET, cervico-thoracic CT, and nasofibroscopy
  • ✓Performance status less than 2
  • ✓Age 18 or older
Key exclusion· 12
  • ✕Prior squamous cell carcinoma of upper aerodigestive tract or facial skin
  • ✕Prior cervico-facial radiotherapy
  • ✕Primary tumor discovered during pan-endoscopy
  • ✕Not suitable for mucosectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04767048
NCT04767048Phase 2RecruitingHigh MomentumUpdated 20mo ago
Long Recruiting
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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

Centre Francois Baclesse·interventional·Posted Feb 23, 2021·Updated Oct 15, 2024

In Brief

A Phase 2 clinical trial evaluating bilateral mucosectomy + tonsillectomy and tonsillectomy for Cancer of Head and Neck and Adenopathy. Currently recruiting, targeting 72 participants across 5 sites.

Signals

Enrolling ahead of pace

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of Head and Neck, Adenopathy
CountriesFrance
Collaborators--

Timeline

Phase 2Recruiting
202120222023202420252026202720282029
First PostedFeb 23, 2021
Enrollment StartJun 30, 2021
Primary CompletionMar 1, 2029
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 5.4 years agoPrimary completion in 2.7 years

Interventions

bilateral mucosectomy + tonsillectomyprocedure

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

tonsillectomyprocedure

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