Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, bronchoalveolar cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)*, including any of the following cellular types: Adenocarcinoma Squamous cell carcinoma Large cell carcinoma Non-lobar and non-diffuse bronchoalveolar cell carcinoma NSCLC not otherwise specified NOTE: *Diagnosed within the past 3 months; diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a distinct lung primary (separate from the nodes) is clearly evident on CT scan Stage IIIA disease T1-T3 disease If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease: Pleural effusion cytologically negative by thoracentesis Documented absence of pleural metastases and pleural effusion cytologically negative by thoracoscopy (for patients with pleural effusion on CT scan [but not on chest x-ray] that is deemed too small to tap safely under either CT scan or ultrasound guidance) Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)**, with or without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy, endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT guidance N2 nodes must be separate from primary tumor by CT scan or surgical exploration AND maximum diameter ≤ 3.0 cm Mediastinoscopy OR other means of mediastinal lymph node biopsy required (regardless of the primary tumor site) for patients with subcarinal lymphadenopathy by size criteria or by positron emission tomography (PET) scan If the lymph nodes in the contralateral mediastinum and neck are visible by contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral involvement is suggested by PET scan, lymph nodes must be confirmed negative by one of the above diagnostic procedures AND N3 status must be confirmed negative by histology or cytology No palpable lymph nodes in the supraclavicular areas or higher in the neck unless proven benign by excisional biopsy A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true: Paralyzed left true vocal cord by bronchoscopy or indirect laryngoscopy Nodes visible in the aortopulmonary window (level 5) region on CT scan Distinct primary tumor (separate from the nodes) is visible by CT scan No evidence of subcarinal nodal involvement by CT scan NOTE: **PET scan positivity is not sufficient to establish N2 nodal status Measurable disease by chest x-ray and/or contrast-enhanced CT scan Candidate for surgery Resectable disease No distant metastases, including other ipsilateral or contralateral parenchymal lesions or liver or adrenal metastases, by history or physical examination, fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT scan of the lungs and upper abdomen PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,800/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed) Hepatic ALT and AST ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 1.5 times ULN No hepatic insufficiency resulting in clinical jaundice or coagulation defects Renal Creatinine clearance ≥ 60 mL/min Cardiovascular No unstable angina or congestive heart failure requiring hospitalization within the past 6 months No transmural myocardial infarction within the past 6 months Pulmonary FEV_1 ≥ 2.0 L OR Predicted post-resection FEV_1 ≥ 0.8 L DLCO ≥ 50% of predicted No chronic obstructive pulmonary disease exacerbation No other respiratory illness requiring hospitalization or that would preclude study therapy Immunologic No AIDS No prior allergic reaction to the study drugs No history of severe hypersensitivity to other drugs formulated with polysorbate 80 No acute bacterial or fungal infection requiring IV antibiotics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No unintentional weight loss > 5% of body weight within the past 6 months No pre-existing peripheral neuropathy ≥ grade 2 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 other severe active comorbidity PRIOR CONCURRENT THERAPY: Biologic therapy No prior biological agent for this cancer No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm) Chemotherapy No prior systemic chemotherapy for this cancer Prior chemotherapy for a different cancer allowed Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields No routine post-operative radiotherapy No concurrent intensity modulated radiotherapy Surgery See Disease Characteristics Other No prior gefitinib for this cancer No concurrent amifostine
Sites / Locations
- Cancer Center at Providence Alaska Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Cancer Care Center at John Muir Health - Concord Campus
- Moores UCSD Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- University of California Davis Cancer Center
- Memorial Hospital
- Front Range Cancer Specialists
- Poudre Valley Hospital
- CCOP - Christiana Care Health Services
- Mayo Clinic - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Watson Clinic, LLC
- CCOP - Mount Sinai Medical Center
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- CCOP - Atlanta Regional
- Northeast Georgia Medical Center
- Delnor Community Hospital - Geneva
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Community Cancer Center
- Advocate Christ Medical Center
- Cancer Treatment Center at Pekin Hospital
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- OSF St. Francis Medical Center
- Cancer Institute at St. John's Hospital
- Reid Hospital & Health Care Services, Incorporated
- Memorial Hospital of South Bend
- Hematology Oncology Associates of the Quad Cities
- Genesis Regional Cancer Center at Genesis Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- St. Agnes Hospital Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Frederick Memorial Hospital Regional Cancer Therapy Center
- Massachusetts General Hospital Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Bronson Methodist Hospital
- Upper Michigan Cancer Center at Marquette General Hospital
- Mayo Clinic Cancer Center
- St. John's Regional Medical Center
- St. John's Regional Health Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Methodist Cancer Center at Methodist Hospital - Omaha
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Valley Hospital - Ridgewood
- NYU Cancer Institute at New York University Medical Center
- SUNY Upstate Medical University Hospital
- Faxton Regional Cancer Center
- Duke Comprehensive Cancer Center
- Leo W. Jenkins Cancer Center at ECU Medical School
- Lenoir Memorial Cancer Center
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Charles M. Barrett Cancer Center at University Hospital
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Veterans Affairs Medical Center - Portland
- Oregon Health & Science University Cancer Institute
- St. Luke's Hospital Cancer Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lancaster General Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Albert Einstein Cancer Center
- Allegheny Cancer Center at Allegheny General Hospital
- York Cancer Center at Apple Hill Medical Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- U.T. Cancer Institute at University of Tennessee Medical Center
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Madigan Army Medical Center - Tacoma
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- Dean Medical Center - Madison
- Vince Lombardi Cancer Clinic - Sheboygan
Arms of the Study
Arm 1
Arm 2
Other
Other
Induction chemotherapy, surgery, consolidation chemotherapy
Chemotherapy and radiation, surgery, consolidation ch
Induction/surgery/consolidation
Induction/radiation/surgery/cosolidation