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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT00103051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary non-small cell lung cancer (NSCLC)
* Clinical stage IIIA by chest CT scan
* Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or video-assisted thoracic surgery
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Planning to undergo lobectomy or pneumonectomy after induction therapy
* No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT scan or ultrasound of the liver and adrenal glands
* No pleural or pericardial effusion
* No superior vena cava syndrome
* No diffuse interstitial pulmonary fibrosis
* No signs or symptoms of CNS involvement
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.25 times ULN
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No medically uncontrolled congestive heart failure or angina pectoris
* No uncontrolled hypertension or arrhythmia
* No myocardial infarction within the past year
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Physically and mentally fit to receive gemcitabine- and cisplatin-containing chemotherapy
* Physiologically fit to undergo surgery
* No uncontrolled, active infection requiring IV antibiotics
* No history of hypersensitivity to gefitinib or any of its excipients
* No motor or sensory neurotoxicity ≥ grade 2
* No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
* No prior melanoma, breast cancer, or renal cell cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent antiestrogen therapy
* Concurrent replacement steroids and antiemetic steroids allowed
Radiotherapy
* No prior radiotherapy for NSCLC
Surgery
* See Disease Characteristics
* No prior surgery for NSCLC
Other
* More than 1 month since prior and no concurrent investigational agents
* No other prior therapy for NSCLC
* No concurrent CYP3A4 inducers, including any of the following:
* Phenytoin
* Carbamazepine
* Rifampin
* Barbiturates (e.g., phenobarbital)
* Hypericum perforatum (St. John's wort)
* No concurrent systemic retinoids
* No other concurrent antitumor therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00103051
Study Brief:
Protocol Section:
NCT00103051