๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 ฮฒHCG will be performed routinely to ensure the absence of pregnancy.
๐
What it tests
- outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
Montpellier, France
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.