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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT00346320
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage I or II peripheral disease
* T1, N0, M0
* T2 (≤ 5 cm), N0, M0
* T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
* No T2-T3 primary tumors \> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
* No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
* Hilar or mediastinal lymph nodes ≤ 1 cm considered N0
* Any of the following primary cancer types:
* Squamous cell carcinoma
* Adenocarcinoma
* Large cell carcinoma
* Bronchioloalveolar cell carcinoma
* Non-small cell carcinoma not otherwise specified
* Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)
* Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
* If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen
* Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs
* No ataxia telangiectasia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)
* No active systemic, pulmonary, or pericardial infection
* No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.
* Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy to the area of the primary tumor
* No prior or concurrent chemotherapy or immunotherapy for this tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00346320
Study Brief:
Protocol Section:
NCT00346320