Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)

Recruiting now · Not applicable

Conditions studied: Cancer T1-N0 or T2-N0 of the Oral Cavity

In brief

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.

Key facts

Study ID

NCT03545256

Run by

University Hospital, Montpellier

People needed

25

Starts

2018-05-31

Expected to finish

2026-07-01

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female over 18 years old with no upper age limit
• Patient (s) affiliated to a social security system, or beneficiary of such a system
• Patient information and informed consent signed by the patient
• Patient no longer participating in another trial since legal time
• Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histological analysis less than 1 month old
• Tumor operable by TNM stage, location and general condition of the patient
• Systematic Oto-Rhino-Laryngology panendoscopy eliminating a second synchronous tumor and establishing precisely the T
• Stage T1 or T2, N0 and M0
• Proposal by a multidisciplinary meeting for tumor surgery and GS technique
• Eligibility criteria for ambulatory surgery present
• Anesthetic criteria for eligibility for outpatient hospitalization (ref AFAR 29 (2010) 67-72, formalized expert recommendations) including ASA I, II and III score stable
• Patient able to understand the nature, purpose and methodology of the study

You may not qualify if…

• lack of one of the inclusion criteria
• other cancer being treated
• non-infiltrating tumor: high grade dysplasia, carcinoma in situ
• insufficient tumor excision: invaded margins without complementary recovery in healthy zone
• contraindication to sentinel lymph node surgery or ganglion dissection
• contraindication to radiotherapy
• contraindications to performing a scintigraphy:
• Known allergy or intolerance to the injected product and in particular to Technetium-99
• Pregnancy
• Refusal to accept the entire treatment (nodal diagnosis on GS, lymph node dissection pN + follow-up of adjuvant radiotherapy if necessary)
• impossible to follow over 2 years
• refusal to accept the monitoring described and / or to provide the information necessary for the study
• patient already treated for this tumor outside of an excisional biopsy
• patient who previously had chemotherapy or immunotherapy for another cancer outside the VADS in a period of less than 6 months
• patient who has had cervical or VADS radiotherapy regardless of the cause or delay
• patient who has had previous cervical surgery regardless of cause or delay
• Patient protected by law (patient under guardianship).
• Patient (e) deprived of liberty by administrative decision.
• Pregnant or lactating women according to article L1121-5 of the CSP. An assay of βHCG will be performed routinely to ensure the absence of pregnancy.

Where it is running

• Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche — Montpellier, Hérault, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.