TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer

This study is being sponsored by a cooperative medical group.

Inclusion criteria

• Signed Informed Consent Form.
• Men or women, age (18 and 70).
• ECOG scale:0-1.
• Life expectancy superior to 3 months.
• Larynx squamous carcinoma histologically demonstrated.
• Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium.
• Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.
• Measurable disease (OMS criteria).
• Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.
• Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)
• Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL.
• Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
• Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
• Use of an effective contraceptive method.

Exclusion criteria

• Metastatic disease
• Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
• Other tumour locations in H&N that are not larynx.
• Other stages that are not III or IVa without metastasis and resectable disease.
• The following cases, which will be considered candidates for radical surgery, will not be included in the study:

• Tumors of the subglottis.
• Tumors of glottis or supraglottis with subglottal extension
• Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues.
• Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula).
• 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 baseline.
• Pregnancy or breastfeeding.
• Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
• Other antineoplasic 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 study by the patient or to grant his/her signature in the informed consent form.
• Known drugs abuse (excepting 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 entry in the study.