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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00530634
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes:
* Adenocarcinoma (no bronchioalveolar cell histology)
* Squamous cell carcinoma
* Large cell carcinoma
* Meeting the following staging criteria:
* Stage IIB (T2, N1, M0, or T3, N0, M0)
* Stage IIIA (T1-3, N2, M0 or T3, N1, M0)
* Stage IIIB (Any T, N3, M0 or T4, Any N, M0)
* No more than 1 parenchymal lesion in the same lung or in both lungs
* No tumor involving the superior sulcus (e.g., Pancoast tumor)
* Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist, and radiation oncologist prior to registration
* No evidence of metastatic disease
* Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or MRI abnormalities that potentially represent metastatic disease
* Biopsy required if all noninvasive tests are indeterminant
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Absolute granulocyte count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* SGOT and SGPT ≤ 3 times ULN
* Creatinine clearance \> 50 mL/min
* No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective protection
* No significant hearing loss or patient unwilling to accept potential for further hearing loss
* No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial infarction within the past 3 months or liver cirrhosis)
* No symptomatic peripheral neuropathy affecting activities of daily living
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy for lung cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00530634
Study Brief:
Protocol Section:
NCT00530634