Outpatient management of early-stage oral cavity cancer
Official title: 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
Run by University Hospital, Montpellier · NCT03545256 · Data updated 2026-11-12
This study is testing a new way to manage early-stage oral cavity cancer in patients by using a technique that could allow them to have surgery and recover at home instead of staying in the hospital.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Montpellier, Hérault) |
| Status | Recruiting |
| Started | May 31, 2018 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT03545256 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with operable T1-N0 or T2-N0 squamous cell carcinoma of the oral cavity or oropharynx.
✕Probably not a fit
Patients with advanced-stage cancer or those requiring extensive surgical intervention may not benefit from this outpatient approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study evaluates the outpatient management of 30 patients with T1-N0 or T2-N0 cancer of the oral cavity or oropharynx. It focuses on the use of a sentinel lymph node technique to minimize hospital stays and assess patient outcomes. The study aims to measure the rate of re-hospitalization within 10 days post-surgery, along with patient acceptance, complications, quality of life, and costs associated with the outpatient approach. The intervention involves a two-stage surgical procedure, including lymphoscintigraphy to identify sentinel lymph nodes prior to surgery.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and improved quality of life for patients undergoing surgery for early-stage oral cavity cancer.
How similar studies have gone: Previous studies have shown promise in outpatient management for similar conditions, suggesting potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
Montpellier, Hérault, France Recruiting
Study contacts
- Principal investigator: Renaud GARREL, ENT — CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department
- Study coordinator: Renaud GARREL, ENT
- Email: r-garrel@chu-montpellier.fr
- Phone: +33 467-336-920
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing treatments for early supraglottic squamous cell carcinoma
This study is testing three different treatment options for early supraglottic squamous cell carcinoma to see which one helps patients feel better and live healthier lives.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.