Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Tumor Stage 1 or 2, Nodes 0 (T1-T2 N0) Operable (SentiMERORL)

This is an interventional treatment trial for Head and Neck Tumors focused on measuring Squamous carcinoma of oral cavity and oropharynx, Sentinel lymph node, Lymph node dissection, Equivalence Read More

Inclusion criteria:

1. Man or woman age over 18 without upper age limit
2. Social Insured
3. Patient Information and Informed Consent signed by the patient
4. Patient not participating in another trial since the legal time
5. Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)
6. Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histopathologic analysis not older than 1 month
7. curable or operable tumor with radiation under the Tumor, Nodes, Metastasis (TNM) stage, location and the patient's general condition
8. Stage T1 and T2
9. Tumor listed N0 satisfying the following conditions (21 days validity period): A) absence of lymphadenopathy palpable on clinical examination of the ENT investigator. B) CT scan or MRI with injection of contrast product: lack of suspicious adenomegaly for metastasis = node size less than one centimeter and 1.5 cm for the group IIa, ovoid, homogeneous, not taking contrast and showing no signs of lymph perinodal invasion ( hyperdensity fat, vascular adhesion), absence of lymph node group (> 3)
10. Systematic ENT endoscopy eliminating a second synchronous tumor and precisely establishing the T (21 days validity period)
11. Absence of metastasis: M0

Exclusion criteria:

1. Failure of one of the inclusion criteria
2. Other cancer being treated
3. Non-invasive tumor: high-grade dysplasia, carcinoma in situ
4. Inadequate tumor excision: margins invaded without further recovery in safe zone
5. Contraindications to surgery such sentinel node or lymph node dissection
6. Contraindications to radiotherapy

7. Contraindications to performing a scan:

   • Known allergy or intolerance to the injected product and particularly with Technetium-99
   • Pregnancy
8. Refusal to accept the full treatment regardless of the strategy
9. Follow-up not possible
10. Refusal to accept the described follow-up and / or provide the necessary information for the study
11. Patient already treated for the tumor outside an excision biopsy
12. Patient who previously had chemotherapy or immunotherapy for another cancer outside VADS within less than 6 months
13. Patient undergoing cervical or VADS radiotherapy whatever the cause or time
14. Patient who have had cervical spine surgery regardless of the cause or time