Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.


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: List of Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

  * Stage III or IV\* disease
  * One of the following primary tumor sites:

    * Oral cavity

      * No mandible invasion
    * Oropharynx
    * Hypopharynx
    * Larynx
  * The following primary tumor sites are excluded:

    * Nasal cavity
    * Paranasal cavity
    * Nasopharynx NOTE: \*No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test abnormalities) or bone scan (for patients with local symptoms)
* At least 1 uni- or bi-dimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* WHO 0-1

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 10 g/dL

Hepatic

* Bilirubin normal
* AST or ALT within eligibility range
* Alkaline phosphatase within eligibility range

Renal

* Creatinine clearance \> 60 mL/min

Cardiovascular

* No unstable cardiac disease despite treatment
* No myocardial infarction within the past 6 months

Pulmonary

* No chronic obstructive pulmonary disease, defined as requiring hospitalization for pneumonia or respiratory decompensation within the past year

  * Obstruction caused by the tumor allowed

Neurologic

* No symptomatic peripheral neuropathy \> grade 2
* No symptomatic altered hearing \> grade 2
* No history of significant neurologic or psychiatric disorders, including dementia or seizures

Other

* No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past 6 months
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery alone
* No active, clinically significant, uncontrolled infection
* No autoimmune disease requiring therapy
* No unhealed or clinically active peptic ulcer disease
* No hypercalcemia
* No other serious illness or medical condition
* No involuntary weight loss \> 25% of body weight within the past 2 months
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy

Surgery

* No prior organ transplantation
* No prior surgery for this cancer

  * Biopsy allowed

Other

* More than 30 days since prior participation in another investigational study
* No other concurrent anticancer therapy
C: DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

  * Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
* No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 mg/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal

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

Cardiovascular

* No symptomatic coronary artery disease (angina)
* No myocardial infarction within the past 6 months

Other

* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* No simultaneous primary tumors
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

* No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease

  * No radical or modified neck dissection
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: B