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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT00979212
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed\* non-small cell lung cancer (NSCLC), including any of the following histologies:
* Adenocarcinoma
* Adenosquamous
* Large cell carcinoma
* Squamous cell carcinoma
* Non-lobar and non-diffuse bronchoalveolar cell carcinoma
* NSCLC not otherwise specified NOTE: \*Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration
* Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)
* N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
* Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm
* N2 status must be pathologically confirmed to be positive by one of the following methods\*:
* Mediastinoscopy
* Mediastinotomy (Chamberlain procedure)
* Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
* Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
* Thoracotomy
* Video-assisted thoracoscopy
* Transbronchial needle biopsy by Wang technique (TBNA)
* Fine-needle aspiration under CT guidance NOTE: \*PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status
* Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:
* Tumor is left sided
* Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
* Nodes visible in the anterior/posterior (level 5) region on CT scan
* Distinct primary tumor separate from nodes visible on CT scan
* Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
* If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are \> 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative
* Measurable disease as determined by contrast-enhanced CT scan
* Primary lung tumor distinct from mediastinal lymph nodes
* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):
* When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
* Exudative pleural effusions are excluded, regardless of cytology;
* Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible.
* No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
* No distant metastases
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
* Creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Serum albumin \> 3.0 g/dL
* Serum magnesium normal (supplementation allowed)
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of treatment
* Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
* Diffusion capacity ≥ 50% predicted
* No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
* No severe, active co-morbidity, including any of the following:
* Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (\<50%)
* Acute bacterial or fungal infection requiring IV antibiotics
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* AIDS or known HIV positivity
* No unintentional weight loss ≥ 5% of body weight within the past 6 months
* No prior severe infusion reaction to a monoclonal antibody
* No pre-existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer
* Prior chemotherapy for a different cancer allowed
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
* No prior therapy that specifically and directly targets the EGFR pathway
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00979212
Study Brief:
Protocol Section:
NCT00979212