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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT02268695
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis squamous cell carcinoma of head and neck: oral cavity, oropharynx, hypopharynx, larynx (histological confirmation is mandatory at least for initial diagnosis)
* Recurrence and/or metastatic disease not suitable for local therapy
* At least one measurable lesion (RECIST) by CT or MRI
* PS \< 2
* Age ≥ 18 years and \< 71 years
* Clearance of creatinine \> 60ml/mn (MDRD)
* Haematological function as follows: absolute neutrophil count \> 1.5 x 109/l, platelet \> 100 x 109/l, hemoglobin ≥ 9.5 g/dl
* Hepatic function as followed: bilirubin ≤ Upper limit of normal (ULN); SGOT/SGPT \< 1.5 ULN; AP \< 2.5 ULN
* Estimated life expectancy \> 12 weeks
* Informed Consent Form signed
* Affiliation to an health insurance
* Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization). Both men and women (of childbearing potential) who are sexually active must use adequate contraception, during and for at least 6 months post-treatment.
Exclusion Criteria:
* Patients with nasopharyngeal cancer, paranasal sinus cancer or unknown primary
* Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
* Surgery (excluding diagnostic biopsy) or radiotherapy within 6 weeks before study entry
* Contra-indication to receive cisplatin
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Administration of prophylactic phenytoin
* Recent or planed yellow fever vaccination
* Prior dose of cisplatin \> 300 mg/m² (a patient who received prior RT + 3 cycles of cisplatin or 3 cycles induction TPF, i.e. total dose of cisplatin ≤ 300 mg/m², for locally advanced primary HN cancer can be included)
* Prior anti-EGFR treatment received less than 12 months before enrolment in the trial
* Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, docetaxel or cetuximab
* Documented or symptomatic brain or leptomeningeal metastasis
* 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
* Malignancies within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
* Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV).
* Significant disease which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
* Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent.
* Pregnant or breast feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
71 Years
Study:
NCT02268695
Study Brief:
Protocol Section:
NCT02268695