Outpatient management of early-stage oral cavity cancer
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT03545256 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with operable T1-N0 or T2-N0 squamous cell carcinoma of the oral cavity or oropharynx.
Not a fit: Patients with advanced-stage cancer or those requiring extensive surgical intervention may not benefit from this outpatient approach.
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 performed: Previous studies have shown promise in outpatient management for similar conditions, suggesting potential for success with this approach.
Eligibility criteria
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 this trial is running
Montpellier, Hérault
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.