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

Summary

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.

Eligibility

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.

Conditions2

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