E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Squamous cell carcinomas of the Head and Neck treated with primary radiotherapy/kemoradiotherapy and randomized to the IMP in question (zalutumumab). |
|
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 |
|
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 |
The main objective is (in an oben randomized trial) to evaluate whether concomitant treatment with curative intended radiotherapy and zalutumumab is better than curative intended radiotherapy alone in patients with squamous cell carcinoma of the head and neck.
|
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the feasibility and tolerability of concomitant treatment with curative intended radiotherapy and zalutumumab.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically proven squamous cell carcinoma of the head and neck. Site: cavum oris, larynx, oropharynx or hypopharynx. All T-stages, all N-stages except all stage I larynx and stage II glottic larynx. Primary tumours with indication for curative intended primary radiotherapy. Age>18 years. WHO performance 0-2. Fertile women must use safe contraception. Informed concent according to local or national laws. The patient is expected to be able to follow treatment, follow-up and required testes and examinations.
|
|
E.4 | Principal exclusion criteria |
Rhinoparynx carcinomas and tumours with unknown origin. Distant metastases. Previous or current malignant disease that could affect current treatment or the prognosis. Previous or current treatment with EGFr-inhibitors. Previous or current surgery, chemotherapy or radiotherapy for malignant disease in the head and neck region. Psycological , familiary, sociological or or geografical relations that could compromize the ability of the patient to follow the protocol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Loco-regional control at 5 years after radiotherapy.
T-site control at 5 years after radiotherapy. Disease-specific survival at 5 years after radiotherapy. Overall survival at 5 years after radiotherapy. Acute and late morbidity. |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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) | 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
| 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 | 5 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |