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 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT00002550
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer
* Eligible subtypes:
* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Nonlobar and nondiffuse bronchoalveolar cell carcinoma
* Measurable or evaluable disease on chest x-ray and/or contrast CT scan
* Contrast thoracic CT required to complete staging
* Single primary bronchogenic tumor (no more than 1 parenchymal lung lesion)
* Pleural effusions allowed if 1 of the following conditions is met:
* Negative cytology on thoracentesis if effusions present before mediastinoscopy or exploratory thoracotomy
* Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
* Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes
* Mediastinal nodes separate from primary lesion on CT scan or surgical exploration
* Histologic or cytologic proof of N2 disease by thoracotomy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle, or fine needle aspiration under bronchoscopic or CT guidance
* Nodal biopsy or aspiration waived if all of the following conditions are met:
* Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
* Nodes visible in Level 5 region on CT scan
* Distinct primary lesion separate from nodes on CT scan
* All mediastinal nodal involvement mapped (positive or negative)
* No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck
* Mediastinoscopy, mediastinotomy, Chamberlain procedure, or thoracotomy required for nodes larger than 1 cm on contrast CT scan
* Surgery waived if nodes negative or no larger than 1 cm on CT scan
* Lymphadenopathy allowed if biopsy proof of a benign cause
* No metastases by contrast CT or MRI scan of the brain, bone scan, CT scan of the lungs to exclude other ipsilateral or contralateral parenchymal lesions, and contrast CT scan of the upper abdomen including entire liver and adrenals
* No hepatomegaly or splenomegaly by physical examination or CT scan unless documentation of a benign cause
* No pericardial effusion
* No superior vena cava syndrome
* No prior diagnosis of lung cancer
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 90-100% (70-80% allowed if albumin at least 0.85 times lower limit of normal and weight loss no greater than 10% within 3 months before diagnosis)
Hematopoietic:
* White blood cell count (WBC) at least 4,000/mm\^3 OR
* Granulocyte count at least 2,000/mm\^3
* Platelet count normal
* Hemoglobin at least 10.0 g/dL (less than 8.5 g/dL allowed if no marrow involvement with tumor)
Hepatic:
* See Performance status
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*
* Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 1.5 times ULN\* NOTE: \* Unless documentation of a benign cause
Renal:
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No myocardial infarction within the past 3 months
* No active angina
* No unstable arrhythmia
* No congestive heart failure
Pulmonary:
* Forced expiratory volume at one second (FEV1) at least 2.0 liters OR
* Predicted postresection FEV1 at least 800 mL based on quantitative V/Q scan
* Diffusion capacity of lung for carbon monoxide (DLCO) at least 50% predicted (corrected for hemoglobin) if pneumonectomy planned or likely after induction chemotherapy
Other:
* No clinically significant hearing loss unless willing to accept the potential of further loss
* No symptomatic peripheral neuropathy
* No peptic ulcer disease under active treatment
* No other medical illness not controllable by appropriate medical therapy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent colony-stimulating factors
Chemotherapy:
* No prior chemotherapy for lung cancer
* No concurrent chemotherapy for another condition (such as arthritis)
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for lung cancer
Surgery:
* See Disease Characteristics
* No prior resection of primary tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002550
Study Brief:
Protocol Section:
NCT00002550