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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT00003803
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Stage I, II, III (T1-4, N0-3, M0)
* No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes
* Medically inoperable or unresectable
* No pleural or pericardial effusion (except with repeated negative cytology)
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 6.8 g/dL
* No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 1.25 times normal OR
* Creatinine clearance greater than 70 mL/min
Cardiovascular:
* No evidence of heart failure
* No myocardial infarction within the past 6 months
* No superior vena cava syndrome
Pulmonary:
* FEV1 at least 1 L
* No pre-existing fibrotic lung disease
* No postobstructive pneumonia preventing exact delineation of tumor volume
* Diffusion capacity at least 60%
Other:
* No weight loss of more than 10% in the past 3 months
* No uncontrolled infection
* No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to the chest
* Maximum length of the esophagus receiving 40 Gy no greater than 18 cm
* Maximum length of the esophagus receiving 66 Gy no greater than 12 cm
* Must limit the spinal cord dose to a maximum of 50 Gy
* Must be able to exclude 25% of the heart from the boost volume
Surgery:
* Not specified
Other:
* No other concurrent experimental medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003803
Study Brief:
Protocol Section:
NCT00003803