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. MedDRA version: 12.0 L
Conditions
Interventions
Trade Name: CETUXIMAB
Product Name: ERBITUX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
Current Sponsor code: EMD271786
Other descriptive name: cetuximab
Concentration un
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
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 1.5 x 10e9/L, platelets > 100 x 10e9/L, hemoglobin > 10.0 g/dL;-Adequate liver function: Bilirubin 60 ml/min - No distant metastases. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ß-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -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;Secondary Objective: - 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.;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 | — |
Countries
Germany
Outcome results
None listed