E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Squamous Cell Carcinoma or the oroplharynx, Larynx or Hypopharynx suitable for radical primary treatment with chemoradiotherapy |
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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 |
To compare the direct costs of erbitux and radiotherapy versus Cisplatin and radiothearpy RT taking in to account drug costs, clinical management and the costs of managing treatment related toxicity. The primary outcome measure of the study is mean overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study.
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E.2.2 | Secondary objectives of the trial |
To document unplanned gaps in both radiotherapy and chemotherapy treatment delivery in both treatment arms To document inpatient hospital admission rates in both treatment arms To assess impact of treatment of Quality of Life To assess median overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with Squamous Cell Carcinoma of the Oropharynx, Larynx and Hypopharynx suitable for radical primary treatment with chemoradiotherapy in the opinion of treating clinical oncologist
Radiotherapy Schedule prescibed to be 70Gy in 35 fractions 5 fraction per week
TNM Stage 3 or 4 ( 7th editiion)
Patient considered sutable to recieve cisplatin therapy in the opinion of treating clinical oncologist
Age 18-70
Expected survival greater than 6 months•
Patient able to give informed consent
•Haematological Parameters at study entry: - • Blood cell counts: Absolute neutrophils > 1.5 x 109/L Platelets > 100 x109/L Haemoglobin > 12 g/dl • Renal function: EDTA-based glomelular filtration rate of > 50 mL/min or a cockcroft gault calculated GFR of > 60 mL/min. • Hepatic functions: Serum bilirubin within normal limits. or AST or ALT < 1.5 x ULN with alkaline phosphatase < 2.5 x ULN.
•Patient compliance and geographic proximity allowing for adequate follow-up.
Female patients potentially able to child bear should use an approved contraceptive method (IUD, birth control pills or barrier device) during and for 3 months after the study. All male patients should take adequate contraceptive precautions during and up to 2 months after the study.
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E.4 | Principal exclusion criteria |
Palliative Radiotherapy
Accelerated Radiotherapy
Prior Radical Surgery for Primary Squamous Cell Carcinoma of the Head and Neck (neck disection is allowed)
Treatment within the last 4 weeks with any investigational drug.
Presence of distant metastases.
Evidence of uncontrolled infection.
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
Neoadjuvant chemotherapy for squamous cell carcinoma of the head and neck prior to study entry.
Preexisiting peripheral sensory neuropathy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure of the study is mean overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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) | Yes |
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
| 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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |