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 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT00104793
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer
* Extensive stage disease
* Newly diagnosed, treatment-naive disease
* At least 1 unidimensionally measurable lesion
* No massive pleural or pericardial effusion by chest CT scan
* Manageable effusions allowed
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* ALT or AST ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine normal
Cardiovascular
* No myocardial infarction within the past year
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No ventricular arrhythmia requiring medical intervention
* No other serious cardiovascular disease
Pulmonary
* Arterial oxygen pressure (Pa O\_2) ≥ 70 mm Hg
* No interstitial pneumonitis or pulmonary fibrosis by chest x-ray
Other
* Not pregnant or nursing
* No uncontrolled diabetes
* No severe infection
* No paralytic or obstructive ileus
* No serious diarrhea
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the chest
* Other prior radiotherapy allowed
Surgery
* At least 2 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00104793
Study Brief:
Protocol Section:
NCT00104793