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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00006012
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer
* Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
* Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest x-ray or a small effusion on CT scan) allowed
* Measurable disease
* At least one lesion accurately measured in at least 1 dimension with longest diameter at least 20 mm
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Pulmonary:
* FEV\_1 at least 40% of predicted AND at least 1 liter
Other:
* No uncontrolled infection
* No other severe underlying diseases
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)
* No grade 2 or greater peripheral neuropathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients of G-CSF
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* No prior hemithorax radiotherapy
Surgery
* Not specified
Other
* No prior therapy for small cell lung cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006012
Study Brief:
Protocol Section:
NCT00006012