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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00754858
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed small cell lung cancer meeting the following criteria:
* Extensive-stage disease
* Previously untreated disease
* At least one measurable disease
* No brain or leptomeningeal metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 2.0 times upper normal limit (ULN) (≤ 5.0 times ULN in the presence of liver metastasis)
* Alkaline phosphatase ≤ 2.0 times ULN
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* No active infection requiring intravenous antibiotics
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer
* No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
* No other concurrent chemotherapy, radiotherapy, or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00754858
Study Brief:
Protocol Section:
NCT00754858