Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenosquamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Squamous, adenosquamous, large cell, or poorly differentiated Stage IIIA (T1-3, N2, M0) N2 disease confirmed by 1 of the following: Mediastinoscopy Bronchoscopy with fine-needle aspiration or esophagoscopy All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (< 1 cm in the largest diameter) PET scan Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (> 1 cm in the largest diameter) All N3 lymph nodes negative in PET scan PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST/ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Cardiac function normal No unstable cardiac disease requiring treatment No congestive heart failure No angina pectoris even if medically controlled No significant arrhythmia No myocardial infarction in the past 3 months Pulmonary: Lung function appropriate Neurologic: No history of significant neurologic or psychiatric disorders No psychotic disorders No dementia No seizures Other: No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years No active uncontrolled infection No uncontrolled diabetes mellitus No gastric ulcers No pre-existing peripheral neuropathy greater than grade 1 No contraindications to corticosteroids No other serious underlying medical condition that would preclude study participation No socioeconomic or geographic condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic chemotherapy Endocrine therapy: No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent) Radiotherapy: No prior radiotherapy to chest Surgery: Not specified Other: At least 30 days since participation in another clinical study No other concurrent experimental drugs
Sites / Locations
- Klinik Loewenstein gGmbH
- Klinikum der Stadt Mannheim
- Institut za plucne bolesti
- Institute of Oncology
- Kantonsspital Aarau
- Kantonsspital Baden
- Kantonsspital
- Saint Claraspital AG
- Universitaetsspital-Basel
- Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
- Inselspital Bern
- Kantonsspital Bruderholz
- Kantonsspital Graubuenden
- Kantonsspital Freiburg
- Hopital Cantonal Universitaire de Geneve
- Centre Pluridisciplinaire d' Oncologie
- Kantonsspital Liestal
- Kantonsspital Olten
- FMH Onkologie/Haematologie
- Kantonsspital - St. Gallen
- Regionalspital
- Kantonsspital Winterthur
- Onkozentrum
- City Hospital Triemli
- UniversitaetsSpital Zuerich
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A
Arm B
Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
Neoadjuvant Chemotherapy + Surgery