Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a national multicenter phase IV study to assess acute radiation dermatitis of combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Heidelberg Medical Center
• Collaborator: iOMEDICO AG
• Treatments: Cetuximab

Criteria

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

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 legal capacity to consent

Note: A combination of the applied radioimmunotherapy with a chemotherapy in terms of a Radioimmunochemotherapy (e.g. with Cisplatin or Carboplatin/5-Fluorouracil) is no exclusion criteria. Furthermore, a patient previously treated with an induction chemotherapy is allowed to participate in this trial.