Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
- Written informed consent.
- Aged between 18 and 80, inclusive.
- Karnofsky functional status >= 70% at the time of enrolment in study.
- Life expectancy of more than 3 months.
- Histologically confirmed diagnosis of oropharyngeal squamous cell carcinoma: base of
tongue, vallecula, tonsil and tonsillar fossa and pillars, glossotonsillar sulcus,
inferior surface of the soft palate, uvula and lateral and posterior oropharyngeal
- Stage III or IV with no evidence of distant metastasis (IVA or IV B)
- Patients in medical conditions to receive a radical concomitant-boost accelerated
- Neutrophils >= 1500/ mm3, platelet count >= 100 000/ mm3 and haemoglobin >= 10 g/ dL.
- Proper liver function: total bilirubin <= 1.5 x upper limit of normal (ULN);
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN.
- Proper renal function: serum creatinine <= 1.5 x ULN; if the values are > 1.5 x ULN,
creatinine clearance should be >= 55 ml/min.
- Serum calcium within normal limits.
- Adequate nutritional state: weight loss < 20% with respect to usual weight and serum
albumin > 35 g/l.
- Effective birth control method if there is possibility of conception and/or
- Availability of tumour tissue for immunohistochemical analysis of EGFR expression.
- Metastatic disease.
- Previous surgical, radiotherapy and/or chemotherapy treatment for the disease in the
- Other non-oropharyngeal tumour sites in the head and neck area.
- Other previous and/or simultaneous squamous cell carcinoma.
- Diagnosis of any other cancer in the previous 5 years, except properly treated
carcinoma in situ of the uterine cervix and/or basal cell skin carcinoma.
- Active infection (infection requiring intravenous antibiotics), including active
tuberculosis and diagnosed HIV.
- Uncontrolled hypertension defined as systolic blood pressure >= 180 mm Hg and/or
diastolic blood pressure >= 130 mm Hg at rest.
- Pregnancy (absence of pregnancy must be confirmed with the serum-HCG test) or
- Chronic, concomitant systemic immunotherapy, or hormonal treatment for the cancer.
- Other concomitant anti-cancer treatments.
- Clinically significant coronary artery disease, history of myocardial infarction in
the previous 12 months or high risk of out of control arrhythmia or cardiac
- Chronic obstructive pulmonary disease which may have required > 3 hospitalisations in
the previous 12 months.
- Out of control active peptic ulcer.
- Presence of a psychological or medical illness which might impede the patient from
carrying out the study or giving his or her signature on the informed consent
- Known drug abuse (with the exception of excessive alcohol consumption)
- Known allergic reaction to any of the components of the treatment to be studied.
- Previous treatment with monoclonal antibodies or signal transduction inhibitors or
other EGFR-targeted treatment.
- Any experimental treatment in the 30 days prior to enrolment in the study.