Hautveränderungen bei Patienten mit Kopf- und Halstumor unter kombinierter RadioImmuno-(chemo)-therapie mit Erbitux® - HICARE-Trial

Conditions: MedDRA version: 18.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
ocally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).

Registration Number: EUCTR2010-019748-38-DE

Lead Sponsor: niversity of Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Histologically confirmed, locally advanced (stage III, IVA or IVB) non-metastatic squamous-cell carcinoma of the oral cavity, oro- or hypopharynx and larynx
- ECOG Performance Status of 0-2
- = 18 years of age
- Life expectancy of at least 6 months.
- Adequate bone marrow, liver and renal function (according to SmPC of Cetuximab) based on laboratory assessments raised within 7 days prior to start of study treatment.
- Signed and dated informed consent before the start of specific protocol procedures.
- Women of childbearing potential must have had a negative serum or urine beta-HCG pregnancy test within 7 days prior to the first administration of study treatment or must have a documented condition that prohibits pregnancy (e.g. post-menopausal; hysterectomy).
- Patients enrolled in this trial must be willing to use effective birth control measures during the course of the trial and the subsequent 2 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Nasopharyngeal carcinoma
- Distant metastases
- Previous radiotherapy for carcinoma of the head and neck
- Participation in other clinical trial (according to the German Drug Law (Arzneimittelgesetz - AMG) within 30 days prior to start of study treatment
- Previous exposure to epidermal growth factor (EGFR) targeted therapy
- Known hypersensitive reaction to any of the components of study treatments
- Previous or concurrent cancer within 5 years prior to study entry that is distinct in primary site or histology except adequately treated basal cell carcinoma or preinvasive cervical carcinoma.
- Pregnant or breast-feeding patients
- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results as judged by the investigator
- Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
- Incapacity to consent or limited capacity to consent