Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Options:
A: Inclusion Criteria:

* Larynx or hypopharynx squamous cell carcinoma proven by histology, locally advanced, only eligible for surgery as total or sub-total (pharyngo-)laryngectomy
* Performance status 0-1
* Neutrophils \>=1.5 x 109/l, Platelets count \>=100 x 109/l, haemoglobin \>=10 g/dl
* Total bilirubin \<= 1.5 x upper reference range
* ASAT and ALAT \<= 2.5 x upper reference range, Alkaline Phosphatases \<= 5 x upper reference range
* Serum creatinine \<= 120 µmol/l
* Weight loss \< 10 % within last 3 months
* Written inform consent

Exclusion Criteria:

* Infiltrative transglottic tumor or clinical cartilage invasion
* Distant metastasis
* Previous chemotherapy or radiotherapy
* Contra-indication to chemotherapy
B: Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx as determined by Hematoxylin and eosin (H\&E) staining

  * Newly diagnosed disease
  * Resectable disease OR disease that is expected to become resectable after study treatment
  * Stage III, IVA, or IVB disease as determined by imaging studies (computed tomography (CT) scan with IV contrast or magnetic resonance imaging (MRI) required) and a complete head and neck exam
* Paraffin-embedded tumor specimen available for central confirmation of HPV-associated disease as determined by H\&E staining and in-situ hybridization (ISH) for HPV-16 and immunohistochemistry (IHC) for p16

  * HPV-associated disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive
  * Non-HPV-associated disease is defined as p16 IHC-negative
  * NOTE: If there is limited tumor material, p16 IHC will be performed before HPV-16 ISH
* Measurable disease of the primary tumor or nodes by clinical and radiographic methods, defined as a lesion that is ≥ 2 cm in at least one dimension by clinical exam AND by radiographic exam with CT scan or MRI (or a lesion that is ≥ 1 cm in at least one dimension if the radiographic exam utilizes spiral CT scan)
* No primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine
* No evidence of distant metastases
* Eastern Cooperative Oncology Group performance status 0-1
* Granulocytes ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total serum bilirubin ≤ 1.5 mg/dL
* Creatinine clearance ≥ 60 mL/min
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of another malignancy (except for carcinoma in situ of the cervix and/or nonmelanomatous skin cancer) unless it has been curatively treated and the patient has been disease-free for ≥ 2 years
* Patients with any of the following within the past 6 months are eligible provided they have been evaluated by a cardiologist and/or neurologist before study entry:

  * New York Heart Association (NYHA) class III-IV congestive heart failure
  * Cerebrovascular accident or transient ischemic attack
  * Unstable angina
  * Myocardial infarction (with or without ST elevation)

Exclusion Criteria:

* Prior chemotherapy
* Prior radiotherapy above the clavicles
* Prior surgery with curative intent for this disease (complete head and neck exam with biopsy allowed)
* Prior therapy specifically and directly targeting the EGFR pathway
* Prior severe infusion reaction to a monoclonal antibody
* Uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within the past 30 days
* Concurrent illness likely to interfere with study therapy or to prevent surgical resection
* Pregnant or nursing
C: DISEASE CHARACTERISTICS:

* Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx

  * Stage III OR
  * Stage IV without distant metastases
* Measurable disease
* Tumor tissue available for immunohistochemical assay of epidermal growth factor receptor expression

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 1 year

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
* Calcium normal

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Medically able to withstand a course of definitive radiotherapy
* No medical or psychologic condition that would preclude informed consent or compliance
* No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior cetuximab or other murine monoclonal antibody

Chemotherapy:

* At least 3 years since prior systemic chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to head and neck
* No other concurrent radiotherapy

Surgery:

* No prior surgery for indicator lesion except biopsy
* Study radiotherapy must not be a part of a postoperative regimen after primary surgical resection
D: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
* Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
* Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
* Nasopharyngeal carcinoma

Answer: C