E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable. |
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MedDRA Classification |
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 |
Locoregional tumour control 1 year |
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E.2.2 | Secondary objectives of the trial |
Overall survival response after induction chemotherapy overall response rate to avaluate safety and toxicity of the treatment to assess quality of life outcome in relation to molecular protein and genetic factors |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically confirmed squamous cell carcinoma of the head and neck - stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable. Patients must have evaluable and/or measureable disease Age ≥18 years Performance status (WHO) of 0-1. Patient must have a life expectancy of at least 3 months allowing adequate follow-up of toxicity evaluation. Previously untreated with chemo-, immuno- or radiotherapy Adequate hematological function defined as WBC ≥3 x 109/litre and platelets ≥100 x 109litre, ANC ³1.5 x 109litre and HB > 100 g/L Adequate renal function defined as creatinine clearence ≥ 50 ml/min Written informed consent must be obtained according to the local Ethics Committee requirements. |
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E.4 | Principal exclusion criteria |
Patient with distant metastatic disease Oral stage I-II, oropharyngeal ca T1-T2 or N0-N1, nasopharyngeal, lipcancer, glottic ca stage I-II and cancer of the paranasal sinuses. Previous or some other concomitant malignancy, less than 5 years, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer Inability to follow the treatment and evaluation schedule Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of interfere with the study objectives Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment Known hypersensitivity to any of the components of the treatment Pre-existing history of severe lung disease Legal incapacity. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical benefit (CR or, PR or SD) after 12 months. |
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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 | Yes |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
Last visit of 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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |