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

This study schedules the screening visit (V0) and then 9 follow-up visits during 24 months.

At the screening, after verification of the eligibility criteria and signature of the informed consent form, the subject will be randomized in one of 2 arms. At the inclusion the following exams have to be done : clinical exam, panendoscopy, cytologic and histologic analysis and CT-Scan (or MRI). For each visit, the investigator will perform a clinical exam and the subjects should complete some questionnaires themselves from V0 to V3, V6 (12 months) and V9. At the last visit (24 months) the patients will have a CTC-Scan ou MRI.

At the end of the follow-up period (24 months), the data of subjects survival will be recorded during three years.

Inclusion criteria

• Man or woman age over 18 without upper age limit
• Social Insured
• Patient Information and Informed Consent signed by the patient
• Patient not participating in another trial since the legal time
• Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)
• Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histopathologic analysis not older than 1 month
• curable or operable tumor with radiation under the Tumor, Nodes, Metastasis (TNM) stage, location and the patient's general condition
• Stage T1 and T2
• 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)
• Systematic ENT endoscopy eliminating a second synchronous tumor and precisely establishing the T (21 days validity period)
• Absence of metastasis: M0

Exclusion criteria

• Failure of one of the inclusion criteria
• Other cancer being treated
• Non-invasive tumor: high-grade dysplasia, carcinoma in situ
• Inadequate tumor excision: margins invaded without further recovery in safe zone
• Contraindications to surgery such sentinel node or lymph node dissection
• Contraindications to radiotherapy
• Contraindications to performing a scan:

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