Clinical trial NCT00268372 (phase 3, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: cisplatin, docetaxel, 5-fluorouracil
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, FC1=CNC(=O)NC1=O
Reason stopped: 
    swog eliminated its head and neck committee
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the oropharynx by biopsy or fine
             needle aspiration of the primary lesion or neck mass

               -  Selected stage III or IV disease

                    -  No T1-2, N1 disease

                    -  No T4b disease

               -  No other primary tumor sites or unknown primary tumor sites

               -  Previously untreated disease

          -  Measurable or non-measurable disease by clinical exam, CT scan or MRI

          -  Disease considered to be curatively resectable

               -  Patients for whom surgical excision is unlikely to result in clear margins are
                  not eligible, including patients with any of the following:

                    -  Gross extension of tumor to skull base (e.g., T4b disease)

                    -  Severe trismus

                    -  Pterygoid plate erosion

                    -  Sphenoid bone or foramen ovale involvement

                    -  Direct extension to involve prevertebral-fascia

                    -  Extension to superior nasopharynx or eustachian tube

                    -  Direct extension into the neck with involvement of the deep neck musculature
                       (neck node fixation)

                    -  Suspected invasion (encasement) of the common or internal carotid arteries
                       (T4b)

                    -  Direct extension of neck disease to involve the external skin

                    -  Regional metastases to the supraclavicular neck (IVB low level VB nodes)

          -  Disease must be appropriate for definitive radiotherapy with curative intent

          -  No evidence of distant metastases (M1)

               -  Must have negative chest x-ray

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  No myocardial infarction within the past 3 months

          -  No unstable or uncontrolled angina

          -  No active systemic infection

          -  Granulocyte count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Creatinine < 1.5 mg/dL

          -  Bilirubin normal

          -  Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

          -  SGOT or SGPT ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No history of hypersensitivity reaction to products containing polysorbate 80

          -  No medical contraindication to surgery as defined by the treating institution

          -  No clinically significant motor or sensory neuropathy ≥ grade 2

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer
             from which the patient is in complete remission

        PRIOR CONCURRENT THERAPY:

          -  No prior therapeutic surgery for head and neck cancer

          -  No prior radiotherapy

          -  No prior chemotherapy