E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced squamous cell carcinoma of head and neck (SCCHN) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of induction chemotherapy with Cetuximab+Docetaxel+Cisplatin +5-FU followed by Cetuximab + radiotherapy in the responders in SCCHN patients. Rate of complete clinical response (imaging and physical examination) will be assessed at 3 months after the end of treatment
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E.2.2 | Secondary objectives of the trial |
- safety and toxicity of the combination of cetuximab and chemotherapy with docetaxel+cisplatin+fluorouracil (TPF), - safety and toxicity of the combination of cetuximab and radiotherapy - response rate after induction chemotherapy, - SUV changes of tumour measured by PET scan at baseline and at the end of study (optional measurement)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed written informed consent - Male or female >18 years of age - Newly diagnosed, histologically confirmed squamous cell carcinoma of the oral cavity,oropharynx, hypopharynx or larynx; locally advanced, resectable disease - Presence of at least one bidimensionally measurable index lesion - Declaration of two independent head and neck surgeons in the context of a multidisciplinary tumor conference on the operability of the patient, and description of planned type of surgery in case if the patient will be non-responder - Written declaration of the patient, that he/she prefers primary non surgical treatment after detailed information concerning both treatment modalities, procedures and consequences - Karnofsky Performance Status ≥ 80 at study entry - Effective contraception for both male and female subjects if risk of conception exists - Bilirubin level ≤ 1.5 x ULN - AST and/or ALT ≤ 2.5 x ULN - Serum creatinine ≤1.5 x ULN - Leukocytes count ≥ 3 x 109/L, neutrophils ≥ 1.5 x109/L, platelets > 100 x 109/L, and hemoglobin > 9 g/dL
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E.4 | Principal exclusion criteria |
- Metastatic disease - Any kind of previous therapy for SCCHN (excluding diagnostic biopsy) - Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol - Participation in another clinical trial within 30 days prior to study entry - Previous administration of EGFR pathway-targeting therapy - Clinically relevant coronary artery disease, history of myocardial infarction within the last 6 months, or high risk/uncontrolled arrhythmia - Known grade 3 or 4 allergic reaction to any of the components of the treatment - Pregnancy (absence confirmed by serum/urine HCG in premenopausal women) or breast-feeding - History of severe pulmonary disease - Any investigational agents within the past 30 days - Having previously participated in a study which included the possibility of being allocated to cetuximab therapy (whether or not the subject actually received cetuximab) - Other previous malignancies within 5 years, with exception of a history of adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Known drug abuse - Legal incapacity or limited legal capacity - Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint of the study is defined as the ratio of the number of patients with complete response (CR) at the 25th week, and the number of the patients who receive further cetuximab therapy at the 6th week. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |