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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01218594
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age
* untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
* weight loss of less than 10% in the past 6 months
* performance status (PS) of 0 to 1
* forced vital capacity in 1 second (FEV1) higher than 0.8 L
* measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
* absolute neutrophil count (ANC) of ≥ 1500/μL
* hemoglobin ≥ 10 mg/dL
* platelet ≥ 100,000/μL
* serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
* calculated creatinine clearance (CrCl) of ≥ 60 ml/min
* bilirubin 1.5×ULN
* AST and ALT less than 2.5×ULN
* alkaline phosphatase less than 5×ULN.
Exclusion Criteria:
* active infection
* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* malnutrition (loss of ≥ 20% of the original body weight)
* sensor or motor neuropathy \> grade I
* second primary malignancy, except for non-melanoma skin cancer
* psychiatric illness or social situation that would preclude study compliance
* pregnant or lactating women
* preexisting bleeding diatheses or coagulopathy
* Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01218594
Study Brief:
Protocol Section:
NCT01218594