Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma
- Patient informed consent must be signed before to start the study.
- Age between 18 to 70 years.
- Performance Status 0-1 according to ECOG scale at the moment of inclusion.
- Life expectancy >3 months.
- Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx
carcinoma III or IV stage without evidence of distance metastasis, which surgery
involve a total laryngectomy.
- T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both
locations it will be required III or IVA stage.
- Patients in medical conditions to receive neoadjuvant treatment with TPF followed by
hyperfractionated radiotherapy combined with cetuximab.
- Presence of a injury measurable with RECIST criteria.
- Neutrophils > or = 1500/mm3, platelets > or = 150.000/mm3 and haemoglobin > or =10
- Renal Function appropriate
- Hepatic Function appropriate
- Serum Calcium tight to albumine < or = 1,25 x upper normal limit (UNL).
- Nutritional status appropriate: weight loss < 20% and albumine > or = 35 g/L.
- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.
- Metastatic disease.
- Surgical treatment, radiotherapy and/or previous chemotherapy.
- Another tumour locations in head and neck area different from larynx or hypo larynx.
- Another stages different from III or IVa without distant metastasis and resectable
- Another previous scaly carcinoma
- Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ
and/or basocellular cutaneous carcinoma adequately treated.
- Active infection treated by ATB IV, including active tuberculosis and VIH.
- Hypertension not controled defined as systolic > or = 180 mm Hg and/or diastolic > or
=130 mm Hg at rest.
- Pregnant/lactating women.
- Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
- Another antineoplastics concomitant treatments.
- Coronary artery disease or history of heart attack in the last 12 months or high risk
of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
- EPOC that required more than 3 hospitalizations in the last 12 months.
- Active ulcus not controled.
- Psychiatric illness/social situations that would limit compliance with study
- Drug abuse (except alcohol abuse)
- Knowledge of Allergic to study treatment.
- Previous treatment with Monoclonal antibodies.
- Any experimental treatment in the previous 30 days to start the study.