Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx or larynx (T2-4, NX, M0). MedDRA version: 9.1 Level: LLT Classification code 10041849 Term: Squamous cell carcinoma of the hypopharynx MedDRA version: 9.1 Level: LLT Classification code 10023856 Term: Laryngeal squamous cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10031112 Term: Oropharyngeal squamous cell carcinoma
Conditions
Interventions
Trade Name: Erbitux,
Product Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent, 2. Age of 18 to 70 years, 3. Life expectancy of at least 6 month, 4. Ability of subject to understand character and individual consequences of clinical trial, 5. Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of the oro-, hypopharynx or larynx (T2-4, NX,M0), 6. Oral cavity or oro- or hypopharynx as the primary tumor site, 7. At least one uni-measurable lesion according to the RECIST criteria, 8. Karnofsky Performances Status > 70%, 9. Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 10.0 g/dL, 10. Adequate liver function: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy, radiotherapy or surgery for carcinoma of the head and neck, 2. Nasopharyngeal Carcinoma, 3. Prior exposure to EGFR pathway targeting therapy, 4. Other serious illness or medical conditions: Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, Significant neurologic or psychiatric disorders including dementia or seizures, Active disseminated intravascular coagulation, Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study, Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher, Ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass, 5. Participation in other interventional trial within the last 30 days§§, 6. Surgery within the last 30 days, 7. Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment, 8. Women: pregnant or breast-feeding, 9. Known drug abuse, 10. Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, 11. Legal incapacity or limited legal capacity, 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the therapeutic efficacy of a combination of radiochemotherapy (IMRT + 5-fluorouracil and carboplatin) and cetuximab on the basis of Local-Regional Control (LRC). ;Secondary Objective: To investigate the therapeutic efficacy and safety of a combination of radiochemotherapy (IMRT + 5-fluorouracil and carboplatin) and cetuximab on the basis of: -Disease-free Survival, -Progression-free Survival, -Overall Survival, -Acute Radiation Effects, -Late Radiation Effects, -Adverse Events, -Proteomics and Genomics. ;Primary end point(s): Local Regional Control: The time to event for local regional control will be calculated with a Cox proportional hazard model. The two-year event rate will be derived from the intercept estimate of the model, along with a 95 per cent confidence interval. | — |
Countries
Germany
Outcome results
None listed