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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01336894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Lung nodule suspicious for non-small cell lung cancer (NSCLC)
* Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria:
* Positive smoking history
* Absence of benign calcifications within suspicious nodule
* Activity on PET greater than normal tissue
* Evidence of growth compared to previous imaging
* Presence of spiculation
* Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration
* All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (\> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy
* Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
* Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions
* Patients with non-peripheral (central) tumors are NOT eligible
* No evidence of distant metastases
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0, 1, or 2
* Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:
* Major criteria
* FEV1 ≤ 50% predicted
* DLCO ≤ 50% predicted
* Minor criteria
* Age ≥ 75 years
* FEV1 51-60% predicted
* DLCO 51-60% predicted
* Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
* Poor left ventricular function (defined as an ejection fraction of 40% or less)
* Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
* pCO2 \> 45 mm Hg
* Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3
* Not pregnant or nursing
* Negative urine or serum pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers).
PRIOR CONCURRENT THERAPY:
* No prior intra-thoracic radiotherapy
* Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted
* Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01336894
Study Brief:
Protocol Section:
NCT01336894