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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT00001450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component.
Eligible Stages Include:
Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven.
CNS Metastases Allowed Provided:
Radiotherapy completed prior to entry.
No requirement for concurrent steroids.
No carcinomatous meningitis.
No epidural metastases.
Measurable disease not required.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy: No prior chemotherapy for lung cancer.
Endocrine Therapy: Not specified.
Radiotherapy: No prior chest irradiation for lung cancer.
Surgery: Prior surgery allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance Status: ECOG 0-2.
Hematopoietic:
Absolute granulocyte count greater than 2,000.
Platelet count greater than 100,000.
Hepatic: Bilirubin no greater than 1.5 mg/dL.
Renal: Creatinine no greater than 1.5 mg/dL.
Cardiovascular:
No CHF unless fully compensated.
No second- or third-degree heart block.
No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.
No sustained ventricular tachycardia.
No MI within 3 months.
OTHER:
No uncontrolled infection unless due to an obstructed bronchus.
No major psychiatric problems requiring hospitalization.
No psychotropic medications such as phenothiazines.
No contraindication to transfusion, if required.
No second malignancy within 5 years except: Nonmelanomatous skin cancer.
In situ cervical cancer.
No pregnant or nursing women.
Effective contraception required of fertile patients.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001450
Study Brief:
Protocol Section:
NCT00001450