Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01553032
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01553032
Study Brief:
Protocol Section:
NCT01553032