NCT03545256 Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
| NCT ID | NCT03545256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Cancer T1-N0 or T2-N0 of the Oral Cavity |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2018-05-31 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2018-05-31 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Renaud GARREL, ENT
PRINCIPAL INVESTIGATOR
CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department
Frequently Asked Questions
Who can join the NCT03545256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer T1-N0 or T2-N0 of the Oral Cavity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03545256 currently recruiting?
Yes, NCT03545256 is actively recruiting participants. Contact the research team at r-garrel@chu-montpellier.fr for enrollment information.
Where is the NCT03545256 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT03545256 clinical trial?
NCT03545256 is sponsored by University Hospital, Montpellier. The principal investigator is Renaud GARREL, ENT at CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department. The trial plans to enroll 25 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.