NCT03545256Recruiting
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
Open Non-randomized Study on the Management of Operable T1-N0 or T2-N0 Oral Cavity and Oropharynx Cancer and Sentinel Lymph Node in Outpatient Surgery
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 7 May 2018
- Start date
- 31 May 2018
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Head and neck cancer
- NCT number
- NCT03545256
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 31 May 2018 to the primary completion date, 1 Jul 2026
- 1 site 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
- contraindication to sentinel lymph node surgery or ganglion dissection
- contraindication to radiotherapy
- Refusal to accept the entire treatment (nodal diagnosis on GS, lymph node dissection pN + follow-up of adjuvant radiotherapy if necessary)
- 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
Other illness
- other cancer being treated
- Known allergy or intolerance to the injected product and in particular to Technetium-99
Other
- lack of one of the inclusion criteria
- non-infiltrating tumor: high grade dysplasia, carcinoma in situ
- insufficient tumor excision: invaded margins without complementary recovery in healthy zone
- contraindications to performing a scintigraphy:
- Pregnancy
- 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 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.