Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• •Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required).
• •Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible.
• •Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria:
• •Unresectable Stage IIIA (N2) patients:
• •* N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection.
• •* N2 status must be documented by any one of the following methods:
• •* Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Wang needle biopsy, fine needle aspiration under bronchoscopic or CT guidance or other method
• •* Node positivity by PET scan
• •* Nodes \>2 cm on CT scan
• •* Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT Scan
• •Stage IIIB patients:
• •Pathologic documented or radiographically documented positive N3 nodes.
• •Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region evidenced by one of the following:
• •* Fine needle aspiration, core needle biopsy or excisional biopsy of supraclavicular N3 nodes
• •* Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
• •* Fine needle aspiration, core needle or Wang needle biopsy under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
• •* Contralateral mediastinal nodes \>2 cm on CT scan
• •* Contralateral node positivity on PET scan
• •* Right sided primary with paralyzed left true vocal cord
• •Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina:
• •* Written documentation of type of T4 extent by attending surgeon if the patient has had an exploratory thoracotomy or thoracoscopy
• •* T4 involvement of the trachea or carina by direct bronchoscopic visualization
• •* T4 involvement of the heart, esophagus, aorta, or vertebral body documented by CT scan, MRI or transesophageal ultrasound
• •* T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is a soft tissue extension directly into the mediastinal space.
• •Radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass.
• •Age \> 18 years
• •ECOG performance status 0 or 1
• •Ability to give informed consent
• •Adequate organ and marrow function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
• •* WBC \> 4,000/µL
• •* Absolute neutrophil count \> 1,500/mm3
• •* Platelet count \> 100 x 103 cells/mm3
• •* Bilirubin \< 1.5 x institutional ULN
• •* AST or ALT \< 2.5 x institutional ULN
• •* Alkaline Phosphatase \<2.5 x institutional ULN
• •* Serum Creatinine \< 2.0mg/dL and/or adequate creatinine clearance
• •Adequate pulmonary function (FEV\>1.5 liters, or if \<1.5 liters, the predicted FEV1of the contralateral lung must be \>800 cc based on the quantitative split function testing. (Predicted FEV1= FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report)
• •Must have one measurable lesion by chest X-ray or CT scan. Lesion(s) must be accurately measured in at least one dimension (longest diameter to be recorded) as \>20mm with conventional techniques or as \>10mm with spiral CT scan
• •Men and women of childbearing potential must agree to use effective contraception while on treatment and for 6 months after treatment