Actively Recruiting
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
Led by University Hospital, Montpellier · Updated on 2025-09-30
25
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.
CONDITIONS
Official Title
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years old or older
- Affiliated with a social security system or beneficiary of such a system
- Provided informed consent and received patient information
- Not currently participating in another clinical trial
- Diagnosed with primary squamous cell carcinoma of the oral cavity or oropharynx confirmed by biopsy within 1 month
- Tumor operable based on TNM stage, location, and patient general condition
- Underwent Oto-Rhino-Laryngology panendoscopy to exclude a second tumor and determine tumor stage
- Tumor staged as T1 or T2, N0, M0
- Surgery and sentinel lymph node technique proposed by multidisciplinary meeting
- Eligible for ambulatory surgery
- Meets anesthetic criteria for outpatient hospitalization including stable ASA I, II, or III score
- Able to understand the study purpose and procedures
You will not qualify if you...
- Missing any inclusion criteria
- Currently treated for another cancer
- Tumor is non-infiltrating such as high grade dysplasia or carcinoma in situ
- Incomplete tumor excision with invaded margins without additional healthy tissue removal
- Contraindication to sentinel lymph node surgery or lymph node dissection
- Contraindication to radiotherapy
- Allergy or intolerance to injected tracer, especially Technetium-99
- Pregnancy
- Refusal to accept all treatments including nodal diagnosis, lymph node dissection if needed, or follow-up
- Unable to be followed for 2 years
- Refusal to accept study monitoring or provide necessary information
- Previously treated for this tumor other than biopsy
- Received chemotherapy or immunotherapy for other cancers in head and neck area within last 6 months
- History of cervical or head and neck radiotherapy
- Previous cervical surgery
- Legally protected patients under guardianship
- Patients deprived of liberty by administrative decision
- Pregnant or lactating women per legal regulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
Montpellier, Hérault, France, 34295
Actively Recruiting
Research Team
R
Renaud GARREL, ENT
CONTACT
C
César CARTIER, ENT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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