Please select the eligibility criteria that correspond to the clinical trial below.
Title: Elective Versus Therapeutic Neck Dissection in the Treatment of Early Node Negative Squamous Cell Carcinoma of the Oral Cavity
Brief Summary: Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.

There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

Primary Objective:

To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e.

therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.

Secondary Objective:

1. Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
2. How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.


Options:
A: 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
B: 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.
C: Inclusion Criteria:

* Patients diagnosed with severe dysplasia, carcinoma in situ, invasive squamous cell carcinoma (T1 or T2) of the oral cavity (ICO-D site codes: C02.0-C06.9) who will be undergoing curative resection (primary disease).

Exclusion Criteria:

* Patients with a non-oral malignancy diagnosed (not including non-melanoma skin cancer and lymphoma outside of head and neck region) within the past 3 years.
* Patients with evidence of distant metastasis (as determined by CAT and X-ray) at the time of recruitment.
D: DISEASE CHARACTERISTICS:

* Patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site
* No clinical or preoperative imaging evidence of nodal involvement in the neck (N0)
* Surgery is the primary mode of treatment

  * Dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon
* No cancer of the lip
* No prior head and neck tumor

PATIENT CHARACTERISTICS:

* No technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms
* Not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team
* No other synchronous tumor
* No preference for non-surgical treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Answer: B