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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00623558
Eligibility Criteria:
Inclusion Criteria:
* Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
* ECOG performance status 0-1
* Age 18 or older than 18 years
* Measurable disease by RECIST criteria
* Having signed informed consent
* ALT and AST\<2.5 times ULN
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Bilirubin level \< 1.5mg/dL
* Serum creatinine \<1.5 times ULN
* WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl
Exclusion Criteria:
* Previous cytotoxic chemotherapy for HNSCC
* Radiotherapy for targeted lesions within six months
* Previous EGFR pathway-targeting therapy
* Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
* Distant metastatic disease
* Heart failure, coronary artery disease, myocardial infarction within the last 6 months
* Known allergy to any study treatment
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
* Legal incapacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00623558
Study Brief:
Protocol Section:
NCT00623558