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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT02119559
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 yo.
* Histologically or cytologically confirmed recurrent and/or metastatic Squamous Cell Carcinoma Head and Neck (SCCHN) (excluding nasopharyngeal carcinoma) not suitable for local therapy : surgery and/or radiotherapy ; or metastatic disease with or without primary evolving tumor.
* Target definable with Response Evaluation Tumors Criteria in Solid (RECIST) 1.1 criteria.
* WHO performance status 0,1 or 2.
* Life expectancy \> 3 month at inclusion.
* Patient eligible for first line chemotherapy based on cisplatin (100 mg/m2 as a 1-hour intravenous (IV) infusion on day 1) or carboplatin (AUC 5 mg/ml.min by 1-hour IV infusion, day 1) and an infusion of 5-FU (1000 mg/m2/day for 4 days) every 3 weeks, with cetuximab (initial dose of 400 mg/m2 \[2-hour IV infusion\] followed by subsequent weekly doses of 250 mg/m2 \[1-hour IV infusion\], ending at least 1 hour before the start of chemotherapy).
* Consent form for participation signed.
Exclusion Criteria:
* Other chemotherapy protocol not involving platinum and cetuximab.
* Other proven synchronous evolving cancer.
* Evolving infectious disease or severe other disease preventing the patient from receiving treatment.
* Patient refusal.
* Patient unable to consent.
* Pregnant or breastfeeding, or premenopausal women not taking effective contraception.
* Current Participation to other clinical trial except experimental molecules.
* Vulnerable persons protected by law.
* People under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02119559
Study Brief:
Protocol Section:
NCT02119559