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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT00032032
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
* Measurable disease
* Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
* No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
* No more than small effusions seen on chest CT scan only
* No supraclavicular adenopathy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
* Direct bilirubin no greater than 1.5 times ULN
* AST no greater than 3 times ULN
Renal:
* Creatinine clearance at least 40 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Pulmonary:
* FEV\_1 at least 1 L or 35% of predicted
Other:
* No grade 2 or greater peripheral neuropathy
* No weight loss of 10% or more within the past 3 months
* No uncontrolled infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
* No other severe underlying disease that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic:
* No prior biologic therapy for NSCLC
* No concurrent biologic therapy
* No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy
Endocrine therapy:
* No prior endocrine therapy for NSCLC
Radiotherapy:
* No prior radiotherapy for NSCLC
Surgery:
* No prior surgery for NSCLC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00032032
Study Brief:
Protocol Section:
NCT00032032