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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT00004859
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
* Squamous cell
* Adenocarcinoma
* Large cell undifferentiated
* Bronchoalveolar
* Non-small cell carcinoma not otherwise stated
* Unresectable stage IIIA
* Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability
OR
* Stage IIIB disease without significant pleural effusion
* Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative
* Metastases to contralateral, mediastinal, or supraclavicular nodes allowed
* Bidimensionally measurable or evaluable disease
* 18 and over
* ECOG performance status 0-1
* Adequate hematopoietic, hepatic, and renal function obtained \<=4 weeks prior to registration:
* Platelet count at least 100,000/mm\^3
* White Blood Cell (WBC) count at least 4,000/mm\^3 OR absolute neutrophil count at least 2,000/mm\^3
* Bilirubin normal
* Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
* Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
* Concurrent filgrastim (G-CSF) allowed for persistent neutropenia
Exclusion Criteria:
* Positive pregnancy test,pregnant or nursing
* Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
* Serious cardiac arrhythmias requiring medication
* Prior radiotherapy to only area of measurable or active tumor
* Less than 5 years since prior chemotherapy
* Other active malignancies
* Serious uncontrolled active infection
* Evidence of greater than grade 1 neuropathy by history or physical examination
* History of seizure disorders
* Contraindication to daily low-dose (81 mg/day) aspirin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004859
Study Brief:
Protocol Section:
NCT00004859