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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT00280150
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of non-small cell lung cancer
* Stage IIIA or IIIB disease
* No malignant pleural or pericardial effusions
* No palpable supraclavicular adenopathy
* Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)
* Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Hemoglobin ≥ 9.0 mg/dL
* Platelet count ≥ 100,000/mm³
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Forced expiratory volume 1 (FEV\_1) ≥ 1 L
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
* Bilirubin normal
* Partial thromboplastin time (PTT) and international normalized ratio (INR) normal
* Urine protein:creatinine ratio \< 1.0
* Blood pressure ≤ 150/100 mm Hg on 3 separate occasions
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant recent hemoptysis (\> ½ teaspoon of bright red blood)
* No unstable angina
* No New York Heart Association (NYHA) congestive heart failure ≥ class II
* No myocardial infarction or stroke within the past 6 months
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious, non-healing wound, ulcer, or bone fracture
* No thrombosis requiring therapeutic anticoagulation
* No significant traumatic injury within the last 28 days
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery
* At least 4 weeks since prior and no concurrent participation in another experimental drug study
* At least 4 weeks since prior and no concurrent major surgical procedure or open biopsy
* At least 2 weeks since prior mediastinoscopy or mediastinotomy
* At least 1 week since prior fine needle aspirations or core biopsies
* No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00280150
Study Brief:
Protocol Section:
NCT00280150