Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Conc. Treatment With Cisplatin and Radiotherapy Versus Conc. Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
1. Before the beginning of protocol's specific procedures, the informed consent has to
2. Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and
hypopharynx) stage III-IV, without evidence of metastasis.
3. 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:
3.1.Technically not resectable (includes: evidence of mediastinal dissemination ;
fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation
of the nasopharynx).
3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication
for the surgery.
4. Epidermoid carcinoma histologically demonstrated
5. Measurable disease according to the RECIST criteria .
6. Men or women with age between 18 and 70 years, both inclusive.
7. Functional condition index according to ECOG scale:0-1
8. Patients in medical conditions to be able to receive treatment with TPF induction
followed by normofractionated radiotherapy with cetuximab or cisplatin.
9. 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
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
11. 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
12. Calcium lower or equal to 1,25 x top normal limit.
13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical
weight and albumin superior or equal to 35 g/L.
14. Patients must be accessible for the treatment and the follow-up.
1. Metastatic disease
2. Surgical treatment, previous radiotherapy and/or chemiotherapy for the study disease.
3. Other tumour locations in head and neck that are not oral cavity, oropharynx, larynx,
4. Other stages that are not III or IVM0.
5. Other previous and / or synchronic squamous carcinoma.
6. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of
uterine neck and/or a cutaneous carcinoma basocellular properly treated.
7. Active infection(at needs endovenous antibiotics), including active tuberculosis and
8. 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
9. Pregnancy(absence must be confirmed with the test of beta-HCG) or period of
10. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the
11. Other antineoplastic concomitant treatments.
12. Coronary clinically significant arteriopathy or precedents of myocardial infarction
in the last 12 months or high risk of not controlled arrhythmia or cardiac not
13. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in
the last 12 months.
14. Active non controlled peptic ulcer.
15. Presence of a psychological or medical disease that could prevent to accomplish the
study by the patient or to grant his/her signature in the informed consent form.
16. Known drugs abuse (with the exception of excessive consumption of alcohol)
17. Known allergic reaction to some of the components of the treatment of the study.
18. Previous treatment with monoclonal antibodies or other transduction of the sign
inhibitors or treatment directed against the EGFR.
19. Any experimental treatment in 30 days before the entry in the study.