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Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Montpellier
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In 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.

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๐Ÿ“‹ 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.
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What it tests

  • outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
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Where

1 site
Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
Montpellier, France
๐Ÿค 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.
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