Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab
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ClinicalTrials.gov Identifier: NCT00941135
Recruitment Status :
First Posted : July 17, 2009
Last Update Posted : September 29, 2011
Fundacion Miguel Servet
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
To evaluate the progression free time in patients with completed or partial response > 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 g/dL.
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.