Locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN). MedDRA version: 18.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Other descriptive name: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate of radiation dermatitis Grade 3/4;Secondary Objective: - Rate of radiation dermatitis Grade 1/2 - Rate of cetuximab-mediated acneiform rash Grade 1-4 - Rate of cetuximab-mediated rhagades Grade 1-4 - Rate of cetuximab-mediated nail changes Grade 1-4 - Objective response rate (ORR) - Locoregional control (LRC) - Progression free survival (PFS) - Overall survival (OS) - Safety profile - Median dose density of radiation - Safety profile of applied radiation protocol - Quality of Life (QoL);Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: Ongoing (during the entire treatment and follow up) and after end of the trial (including FU) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of radiation dermatitis Grade 1/2 - Rate of cetuximab-mediated acneiform rash Grade 1-4 - Rate of cetuximab-mediated rhagades Grade 1-4 - Rate of cetuximab-mediated nail changes Grade 1-4 - Objective response rate (ORR) - Locoregional control (LRC) - Progression free survival (PFS) - Overall survival (OS) - Safety profile - Median dose density of radiation - Safety profile of applied radiation protocol - Quality of Life (QoL);Timepoint(s) of evaluation of this end point: a) Ongoing (during the entire treatment and follow up): - Rate of radiation dermatitis Grade 1/2 - Rate of cetuximab-mediated acneiform rash Grade 1-4 - Rate of cetuximab-mediated rhagades Grade 1-4 - Rate of cetuximab-mediated nail changes Grade 1-4 b) End of the trial (including FU) - Objective response rate (ORR) - Locoregional control (LRC) - Progression free survival (PFS) - Overall survival (OS)- Safety profile - Median dose density of radiation - Safety profile of applied radiation protocol - Quality of Life (QoL) | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Dr. Jürgen Debus
University of Heidelberg
Outcome results
None listed