Last updated on May 2019

TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Head and Neck Cancer
  • Age: Between 18 - 70 Years
  • Gender: Male or Female
  • Other:
    Before the beginning of protocol's specific procedures, the informed consent has to
    be obtained.
    Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and
    hypopharynx) stage III-IV, without evidence of metastasis.
    The tumor must be considered to be non-operable according to the criteria of the
    Northern California Oncology Group. The reason of non-surgical resection will be
    annotated in the CRF.
    Criteria of non-surgical resection according to the NCOG:
    1.Technically not resectable (includes: evidence of mediastinal dissemination ;
    fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation
    of the nasopharynx).
    2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication
    for the surgery.
    Epidermoid carcinoma histologically demonstrated
    Measurable disease according to the RECIST criteria .
    Men or women with age between 18 and 70 years, both inclusive.
    Functional condition index according to ECOG scale:0-1
    Patients in medical conditions to be able to receive treatment with TPF induction
    followed by normofractionated radiotherapy with cetuximab or cisplatin.
    Patients with adequate hematologic function: neutrophils superior or equal to 2 x
    109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10
    Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and
    GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal
    Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4
    mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for
    Cockcroft-Gault's method).
    Calcium lower or equal to 1,25 x top normal limit.
    Adequate nutritional condition: loss of weight <20% with relation to the theoretical
    weight and albumin superior or equal to 35 g/L.
    Patients must be accessible for the treatment and the follow-up.

You may not be eligible for this study if the following are true:

  • Metastatic disease
    Surgical treatment, previous radiotherapy and/or chemiotherapy for the study disease.
    Other tumour locations in head and neck that are not oral cavity, oropharynx, larynx,
    Other stages that are not III or IVM0.
    Other previous and / or synchronic squamous carcinoma.
    Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of
    uterine neck and/or a cutaneous carcinoma basocellular properly treated.
    Active infection(at needs endovenous antibiotics), including active tuberculosis and
    diagnosed HIV.
    Not controlled hypertension defined as arterial systolic tension superior or equal to
    180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg
    Pregnancy(absence must be confirmed with the test of beta-HCG) or period of
    Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the
    Other antineoplastic concomitant treatments.
    Coronary clinically significant arteriopathy or precedents of myocardial infarction
    in the last 12 months or high risk of not controlled arrhythmia or cardiac not
    controlled insufficiency.
    Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in
    the last 12 months.
    Active non controlled peptic ulcer.
    Presence of a psychological or medical disease that could prevent to accomplish the
    tudy by the patient or to grant his/her signature in the informed consent form.
    Known drugs abuse (with the exception of excessive consumption of alcohol)
    Known allergic reaction to some of the components of the treatment of the study.
    Previous treatment with monoclonal antibodies or other transduction of the sign
    inhibitors or treatment directed against the EGFR.
    Any experimental treatment in 30 days before the entry in the study.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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