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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT00560495
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
* Squamous, large cell undifferentiated, or adenocarcinoma
* Sputum cytology not acceptable evidence of cell type
* Cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion allowed
* Stage I-IIIB disease
* No evidence of distant metastases
* Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for gross residual disease or positive margin)
* Medically inoperable disease or chemotherapy or surgery refused
* Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan, unless definitive CT-positive mediastinal disease is noted
* If patient cannot tolerate mediastinoscopy and no PET is available, the technetium 99m sestamibi scan is allowed for assessment of the mediastinum
* No stage IIIB disease with pleural effusions or stage IV disease
* No small cell lung cancer or mixed small cell/non-small cell histology
PATIENT CHARACTERISTICS:
* SWOG performance status 0-2
* Hemoglobin ≥ 9.0 g/dL
* WBC ≥ 3,000/mm³
* ANC ≥ 1,200/mm³
* Platelet count ≥ 80,000/mm³
* Creatinine \< 1.8 mg/dL
* Prior malignancy allowed if disease free for ≥ 5 years
* Nonmelanoma skin cancer allowed within 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the radiation oncologist has concerns about a 3-week delay in treatment)
* No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction where the radiation oncologist has concerns about a 3-week delay in treatment)
* No transfusion dependence requiring \> 2 units of packed RBCs every 2 weeks for more than 28 days
* No medically serious acute or chronic medical condition that is unstable and/or requires intensive management
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior thoracic radiation allowed if the new lesion can be treated with absolutely no overlap of previous treatment fields
* At least 3 weeks since prior surgery
* No concurrent chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00560495
Study Brief:
Protocol Section:
NCT00560495