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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT00995761
Eligibility Criteria:
Inclusion Criteria:
* patients who were≥ 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were \< 65 years of age and they had an ECOG PS 2
* histologically confirmed non-small cell carcinoma
* stages IIIB-IV disease
* adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dL), and liver function (total bilirubin ≤1.5 mg/dL and serum transaminase level less than twice the upper limit of normal)
* at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion Criteria:
* Active infection
* Prior chemotherapy, radiotherapy or surgery for their disease,
* A history of myocardial infarction in the last 3 months before entry to the study
* Uncontrolled congestive heart failure or hypertension
* Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
* All the patients provided written informed consent before they entered the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00995761
Study Brief:
Protocol Section:
NCT00995761