E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This trial includes Patients with locally advanced squamous cell carcinoma of the head and neck (SCCH&N). In SCCH administration of chemotherapy of 5-FU and Cisplatin is a standard therapy. Herel the additional administration of cetuximab and radiotherapy under prior tumor resection is tested. Both therapies are each authorised therapies. The safety and efficacy of the combined therapies, especially on locregional recurrence of squamous cell carcinoma, will be evaluated. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
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 |
-Rate of patients experiencing grade 3/4 acute toxicities (acute tox. means any tox. occurring within 90 days post radiation start – not considering grade 3/4 skin tox. outside the radiation portals) -The 2-years disease-free survival rate |
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E.2.2 | Secondary objectives of the trial |
- The cumulative incidence of loco-regional relapses as defined in the protocol - Disease-free survival defined as the time from start of surgery to the first evidence of loco-regional or distant tumor relapse, second primary tumor, or death due to any cause. If the patient has no evidence of the before mentioned events, disease-free survival is censored at the time of last documented efficacy. - Progression-free survival defined as the time from start of surgery to the first observation of disease progression or death due to any cause. - Overall survival is defined as the time from treatment start to time of death due to any cause. - The rate of patients with secondary primary neoplasm. - The incidence of late toxicity, defined as all adverse events occurring beyond 90 days after start of radiation therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-written informed consent - Male or female patients between 18 and 70 years -Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than maximum 9 weeks ago -To be categorized as high risk, patients have to fulfil at least one of the following criterias: (R0 - resection <5 mm margin or R1 – resection or Extracapsular nodal extension) -No previous chemotherapy and/or radiotherapy for carcinoma of the head and neck -Performance status ECOG: 0 – 1 -Contraception in female partners of male patients and female patients with willingness to use effective contraceptive method for the study duration and 2 months post-dosing -Adequate renal, liver and hematological functions within 9 weeks until surgery: (-Adequate bone marrow function: neutrophils > 1.5 x 10e9/L, platelets > 100 x 10e9/L, hemoglobin > 10.0 g/dL;-Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, γ-GT < 3 x ULN) -Adequate renal function: creatinine clearance > 60 ml/min - No distant metastases. |
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E.4 | Principal exclusion criteria |
-Nasopharyngeal carcinoma -R2-resection -Invalid informed consent -Performance Status > 1 -Previous chemotherapy or radiotherapy for carcinoma of the head and neck -Prior exposure to EGFR pathway targeting therapy - Other serious illness or medical conditions:(-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4 or -Clinically significantly abnormal electrocardio-gram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal or-Significant neurologic or psychiatric disorders including dementia or seizures or-Active uncontrolled infection or -Active disse-minated intravascular coagulation or- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study) -Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass -Having participated in another therapeutic 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 β-HCG) or breast-feeding -Known drug abuse of illeagal drugs -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 - Sensitivity and incompatibility against 5-Fluorouracil - Sensitivity and incompatibility against platinum-compounds - Known incompatibilities >grade 3 towards cetuximab - dental evaluation and pre treatment dental care before start of radiochemotherapy - HIV infection |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Rate of patients experiencing grade 3/4 acute toxicities (acute tox. means any tox. occurring within 90 days post radiation start – not considering grade 3/4 skin tox. outside the radiation portals) -The 2-years disease-free survival rate |
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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 | Yes |
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 | 11 |
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 | Yes |
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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Last visit of the last patient (LVLP) |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |