E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preirradiated patients with locally recurrent or with secondary squamous cell carcinoma of the head and neck |
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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 | 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 feasibility rate of cetuximab in combination with re-irradiation |
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E.2.2 | Secondary objectives of the trial |
• Locoregional control rate • Time to progression • Overall survival • Quality of life (EORTC QLQ C-30/QLQ-H&N35) • To determine the overall response rate • Safety and toxicity
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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 age 18 to 65 years • Unresectable histologically confirmed squamous cell carcinoma of the larynx, hypopharynx, oropharynx or oral cavity suitable for re-irradiation and • locally recurrent or development of a second primary tumor after radio- or radiochemotherapy • Minimal interval of 12 months from end of prior radiotherapy • No severe sequelae of the first course of radiotherapy • Expected survival more than 3 months • At least one uni-measurable lesion according to the RECIST criteria Version 1.1 must be present • Karnofsky Performance Score ≥ 70% • Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL • Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, AP, -GT < 3 x ULN • Adequate renal function: serum creatinine < 1.5 mg/dL • If of childbearing potential, willingness to use effective contraceptive methods for the study duration and 2 months post-dosing. • No surgery or any investigational agent within 4 weeks of study entry
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E.4 | Principal exclusion criteria |
• Presence of distant metastases • Prior exposure to EGFR pathway targeting therapy • Severe radiation dermatitis grade 4 during/after previous radiotherapy • Other serious illness or medical conditions: - Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4 - Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal - Significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; • Having participated in another clinical trial or any investigational agent in the preceding 30 days • Known allergic/hypersensitivity reaction to any of the components of the treatment • Pregnancy (absence confirmed by serum/urine -HCG) or breast-feeding • Known drug abuse • Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix • Legal incapacity or limited legal capacity • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility rate of cetuximab in combination with re-irradiation. |
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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 | 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) | 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 | 12 |
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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The end of study is defined as the last Follow-up visit of the last patient. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |