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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00449020
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIA or IIIB disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
* No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Bilirubin normal
* Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
* Creatinine \< 2.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* No New York Heart Association class III-IV heart disease
* No history of serious cardiac disease not adequately controlled
* No documented myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No clinically significant arrhythmia
* No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1
* No other malignancy within the past 5 years other than skin cancer
PRIOR CONCURRENT THERAPY:
* More than 3 weeks since prior major surgery
* No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00449020
Study Brief:
Protocol Section:
NCT00449020