Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of IIb Preserving Neck Dissection VS Neck Dissections Involving IIb Removal (Selective/Functional) in Patients With N0 Neck With Oral Cavity Malignancies
Brief Summary: The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The options include the policy of "wait and watch"(close observation and follow-up), elective irradiation of the neck, elective surgery of the neck (neck dissection).

In elective neck dissections, the procedures commonly performed are modified radical neck dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection depending on the site of the primary lesion within the oral cavity. There are no trials of IIb preserving neck dissection in cancers of the oral cavity.


Options:
A: Inclusion Criteria:

* Histologically proven SCC of the oropharynx; T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0, with only amendable to transoral resection)
* Primary tumor must be resectable through transoral approach
* p16 immunohistochemitry by local pathology or FFPE tissue must be available for central HPV diagnostic
* Written and signed informed consent
* Briefing through surgeon and radiation oncologist
* ECOG PS ≥2, Karnofsky PS ≥ 60 %
* Age ≥ 18
* Curative treatment intent
* Adequate bone marrow function: leucocytes \> 3.0 x 109/L, neutrophils \> 1.5 x 109/L, platelets \> 80 x 109/L, hemoglobin \> 9.5 g/dL
* Adequate liver function: Bilirubin \< 2.0 g/dL, SGOT, SGPT, \< 3 x ULN
* If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
* dental examination and appropriate dental therapy if needed prior to Confidential TopROC 2017_03_24 Version 1.0 Seite 15 von 124 beginning of radiotherapy
* Nutritional evaluation prior to initiation of therapy and optional prophylactic gastrostomy (PEG) tube placement

Exclusion Criteria:

* Prior invasive malignancy except controlled skin cancer or carcinoma in situ of cervix
* Unknown primary (CUP), nasopharynx, hypopharynx, laryngeal or salivary gland cancer
* Metastatic disease
* Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C
* Hemoglobin level \<9.5g/dl within 4 weeks before randomization
* Pregnancy or lactation
* Women of child-bearing potential with unclear contraception
* Previous treatment with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
* Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
* Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol
* Patients institutionalized by official means or court order
* Deficient
B: Inclusion Criteria:

* age 18 or older
* willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Tumour stage:T1 or T2, with likely negative resections at surgery
* Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging.
* Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Metastatic disease
* Inability to attend full course of radiotherapy or follow-up visits
* Neck disease with unknown primary site
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
* unable or unwilling to complete QoL questionnaires
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. 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

Answer: C