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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00005868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)
* Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes
* Measurable disease
* Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan
* No distant metastases
* No CNS involvement
* No pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* AST/ALT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.25 ULN
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No superior vena cava syndrome
* No uncontrolled congestive heart failure or angina
* No myocardial infarction within past year
* No uncontrolled hypertension or arrhythmia
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent active infection requiring IV antibiotic therapy
* No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma
* No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)
* No motor or sensory neurotoxicity of grade 2 or greater
* No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy
Radiotherapy:
* No prior radiotherapy for NSCLC
* No concurrent radiotherapy
Surgery:
* No prior surgery for NSCLC
Other:
* At least 1 month since prior investigational agents
* No other concurrent experimental medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00005868
Study Brief:
Protocol Section:
NCT00005868