Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.
Brief Summary: Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.

This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.

The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.

A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.


Options:
A: Inclusion Criteria:

1. Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT).
2. N0 neck disease on side of the dominant hand
3. Willingness to participate in post-operative physiotherapy

Exclusion Criteria:

1. IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa)
2. Previous neck RT
3. Previous chemotherapy
4. Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance).
5. Previous neck dissection
6. Previous SAN injury or dysfunction
7. Preoperative signs or formal diagnosis of myopathy or neuropathy
8. Previous shoulder injury (muscular or bony)
9. Level V neck dissection
10. Recognized intraoperative sectioning of the SAN
11. Unable to provide informed consent
12. Cardiac pacemaker (contra-indication to EMG/Nerve conduction)
13. Radial forearm free flap on dominant arm
B: 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
C: Inclusion Criteria:

* Patients \>18yrs of age.
* histologically proven squamous cell carcinoma
* clinical and radiological N0 neck

Exclusion Criteria:

* Pregnant and lactating women

  * Patients with synchronous primaries
* H/o previous malignancy except BCC
* Previous surgeries on neck

  * Post radiotherapy recurrence.
D: Inclusion Criteria:

1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
3. No history of a prior malignancy in the head and neck region.
4. No prior malignancy outside the head and neck region in the preceding 5 years.
5. Patient will be reliable for follow-up
6. Age\> 18 years and \< 75 years.
7. No significant co-morbid conditions - ASA grade II and I.
8. Understands the protocol and is able to give informed consent.

Exclusion Criteria:

1. Prior radiotherapy or surgery for malignancy in the head and neck region.
2. Non squamous cell carcinomas of the oral cavity.
3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.

Answer: B