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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01830556
Eligibility Criteria:
Inclusion criteria
* \>18 years
* Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
* Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
* Clinical examination
* 1 unidimensional lesion according to RECIST 1.1.
* PS WHO 0-1 at study entry
* Adequate hematological function defined as WBC ≥3 x 109/litre and platelets ≥100 x 109/litre, ANC \> 1.5 x 109/litre and Hb \> 100 g/L
* Adequate liver function; bilirubin \< 1.5 x UNL, ALAT or ASAT\<3.0 UNL, alkaline phosphates \< 2.5 UNL.
* Creatinine clearance \> 50mL/min
* Written informed consent must be obtained according to the local Ethics committee.
Exclusion Criteria:
* \> 75 years
* Nasopharyngeal cancer and cancer of the paranasal sinuses
* Inability to follow the treatment and evaluation schedule
* Any other condition or therapy which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives
* Pregnant or nursing females or male or female of child-bearing potential not using adequate methods of birth-control
* Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
* Known hypersensitivity to any of the components of the treatment
* Legal incapacity
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
* Patients with clinically relevant neuropathy
* Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated \> 3 months before start of treatment.
* Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01830556
Study Brief:
Protocol Section:
NCT01830556