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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT00248495
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Microscopically confirmed non-small cell lung cancer
* Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA (T1-3, N1-2, M0) disease
* Satellite lesions in one lobe (T4) (stage IIIB) allowed
* Meets 1 of the following criteria:
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm in the longest diameter
* Evaluable disease, defined as lesions on chest CT scan that are not measurable (e.g., ill-defined masses or mediastinal or hilar adenopathy)
* No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2)
* No N3 lymph nodes (e.g., contralateral mediastinal/hilar or supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan AND mediastinoscopy
* No T4 primary tumor (e.g., mediastinal invasion)
* No malignant pleural effusion
* Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate) allowed
* Effusions visible only by CT scan and not large enough for safe thoracentesis allowed
* No exudative effusion, defined by 1 of the following criteria:
* Pleural fluid protein:serum protein ratio \> 0.5
* Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio ≥ 0.6
* Pleural fluid LDH \> 200 IU/L
* No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan
* Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for metastatic disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* SGOT or SGPT ≤ 1.5 times upper limit of normal
Renal
* Creatinine clearance ≥ 45 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for lung cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for lung cancer
Surgery
* No prior surgery for lung cancer
* At least 12 weeks since prior major surgery to the chest and abdomen
Other
* No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for ≥ 2 days before (5 days for drugs with a long half-life \[e.g., naproxen, piraoxicam, difunisal, nabumetone, rofecoxib, or celecoxib\] or 8 days for long acting agents), during, and for 2 days after completion of each pemetrexed disodium administration
* No concurrent participation in another study involving chemotherapy or radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00248495
Study Brief:
Protocol Section:
NCT00248495