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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00281827
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:
* Squamous cell carcinoma
* Adenocarcinoma
* Large cell undifferentiated carcinoma
* Stage II or IIIA disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
* No tumor involving the superior sulcus (e.g., Pancoast tumor)
* Karnofsky performance status 70-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 2 mg/dL
* Bilirubin \< 2 mg/dL
* Aspartate aminotransferase (AST) \< 3 times upper limit of normal
Exclusion Criteria:
* Pregnant or nursing
* No nursing during and for ≥ 4 weeks after completion of study treatment
* Positive pregnancy test
* Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
* Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
* Blood, sperm, or ova donation during study treatment
* Post obstructive pneumonia
* Other serious infection or medical illness that would preclude study participation
* Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
* Less than 5 years since prior resection of lung disease
* Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
* Other concurrent chemotherapy or radiotherapy
* Concurrent hormonal therapy or immunotherapy
* Other concurrent anticancer therapy
* Other concurrent investigational agents
* Concurrent participation in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00281827
Study Brief:
Protocol Section:
NCT00281827