Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Brief Summary: The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.

This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

  * Locally advanced disease, defined by any of the following criteria:

    * Any T, N+, M0
    * T3-4, N0, M0
* No current history of unknown primary squamous cell carcinoma of the head and neck, primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Absolute granulocyte count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 3 times ULN
* Creatinine clearance \> 50 mL/min
* Magnesium \> 0.5 mmol/L
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
* Must be accessible for treatment and follow-up
* Able (sufficiently fluent) and willing to complete the quality of life (QOL) and swallowing QOL questionnaires in either English or French
* Must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation
* No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors
* No history of allergic or hypersensitivity reactions to any of the study drugs or their excipients
* No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) on baseline CT scan
* No peripheral neuropathy ≥ grade 2 (CTCAE v3.0)
* No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0)
* No thromboembolic event within the past 12 months despite being treated with anticoagulation drugs

  * Prior thromboembolic event \> 12 months allowed provided patient is stable on anticoagulation or on preventative anticoagulation
* None of the following allowed:

  * Myocardial infarction within the past 12 months
  * Uncontrolled severe congestive heart failure
  * Unstable angina
  * Active cardiomyopathy
  * Unstable ventricular arrhythmia
  * Uncontrolled hypertension
  * Uncontrolled psychiatric disorder
  * Active serious infection
  * Active peptic ulcer disease
  * Any other medical condition that might interfere with protocol therapy delivery

PRIOR CONCURRENT THERAPY:

* No prior surgical treatment except diagnostic biopsy for this disease
* No prior induction chemotherapy for this disease
* No prior radiation to the head and neck region that would result in overlap of fields for this study
* No prior cisplatin or carboplatin chemotherapy
* No prior targeted anti-EGFR therapy of any kind
* At least 30 days since any prior investigational agent
* No concurrent granulocytic growth factors (e.g., filgrastim \[G-CSF\]) during radiotherapy
* No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or hormonal therapy), or other investigational drug therapy
* The following radiological investigations must be done within 8 weeks of randomization:

  * MRI or CT of the head and neck
  * CT chest
B: Inclusion Criteria:

* Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.
* Inoperable tumor after revision by a multidisciplinary oncology team.
* Proved epidermoid carcinoma.
* ECOG = 0-1
* Good hematologic function (i.e, hemoglobin \> 10 g/dl, ...)
* Good hepatologic function
* Good renal function

Exclusion Criteria:

* Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.
* Nasopharynx, nasal cavity and paranasal sinusitis will be excluded
* Previous chemotherapeutic or radiotherapeutic treatment for this disease.
* Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma
* Symptomatic peripheral neuropathy
* Other clinical severe diseases
* Concomitant treatment with corticoids within 6 months prior to inclusion.
* Concomitant treatment with any other neoplastic therapy
* Previous treatment for current disease.
* Loss of weight greater than 10% within the last 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
C: DISEASE CHARACTERISTICS: Histologically confirmed squamous cell cancer of the head and neck suitable for treatment with radiotherapy T2, T3, or T4 primary lesions Any N No distant metastasis May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma (as of 1/97) No occult primaries (as of 1/97) No adenocarcinomas, lymphomas, or melanomas (as of 1/97) Synchronous head and neck tumors are eligible (tumor with the worse prognosis is entered into study) (as of 1/97) Patients receiving surgery to neck nodes only must be randomized as surgery patients (as of 1/97) Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary

PATIENT CHARACTERISTICS: Age: 75 and under for patients electing participation in the nodal vs. no nodal irradiation portion of the study Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fit for any protocol treatment option Willing to receive any protocol treatment option Prior malignancy allowed provided the treating clinician considers the patient cured

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: Prior biopsy or excision allowed
D: 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

Answer: D