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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01593293
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th)
* Age 70 years old or older
* Eastern Cooperative Oncology Group performance status 0-1
* Measurable or assessable disease as defined by RECIST 1.1
* Estimated life expectancy of more than 3 months
* Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL)
* Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min
* Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 3 x UNL, alkaline phosphatase \< 3 x UNL (except in case of bone metastasis without any liver disease)
* Written informed consent
Exclusion Criteria:
* Prior systemic chemotherapy or biological therapy
* Contraindication to any drug contained in the chemotherapy regimen
* Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment
* Active infection which would compromise the patient's ability to tolerate treatment
* Requirement for major surgery within 4 weeks of study entry
* Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months
* Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration
* Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery)
* Peripheral neuropathy ≥ grade 2
* History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01593293
Study Brief:
Protocol Section:
NCT01593293