E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067821 |
E.1.2 | Term | Head and neck cancer |
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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 study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine. |
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E.2.2 | Secondary objectives of the trial |
To study the toxicity and safety profile of the combination of weekly gemcitabine, weekly cetuximab and daily IMRT in patients with cancer of the head and neck. To determine the time to locoregional relapse, the time to distant metastasis, progression free survival, time to progression, time to treatment failure and the overall survival. To determine the plasma levels of dFdU daily after the first administration of gemcitabine and before each weekly administration thereafter. To evaluate the quality of life before, during and after the treatment using EORTC QLQ-C30 and EORTC QLQ-H&N35. To determine the presence of HPV and p16 in tumor tissue. To determine the presence of EGFRvIII in tumor tissue.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written and signed informed consent Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation Life expectancy of at least 12 weeks Age > 18 years Performance status of 0 or 1 according to the World Health Organization (WHO) Adequate hematologic, cardiac, pulmonary, renal and liver function
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E.4 | Principal exclusion criteria |
Pregnant or lactating women or women of childbearing potential without adequate contraceptive measures. Known brain or leptomeningeal metastasis Other serious medical conditions Congestive heart failure, uncontrolled angina pectoris, uncontrolled hypertension or uncontrolled arrhythmia Active infection History of significant neurologic or psychiatric disorders Known hypersensitivity reactions to cetuximab or gemcitabine or one of the excipients. Altered fractionation radiotherapy. Prior radiotherapy and/or chemotherapy (except as induction chemotherapy) within 6 months before enrolment
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E.5 End points |
E.5.1 | Primary end point(s) |
To study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 3 |
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 | 3 |