Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Brief Summary: Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer


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

* age \> 18 years
* oral cavity scc
* primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

* previous treatment for head and neck cancer
* unable or unwilling to give informed consent
* history of bleeding disorder
* other contraindications to surgery

Answer: C