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RTOG 0412: Phase III Randomized Trail of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with State IIIA (N2) Non Small Cell Lung Cancer

Purpose of trial:

Purpose of this study is to compare the effects of the two treatments on lung cancer to find out which is better. One group will receive chemotherapy followed by surgery. The other group will receive chemotherapy and radiation followed by surgery

Protocol Summary:

Patients are randomized into either Group 1 or Group 2. Group 1 (called Arm 1) will receive two chemotherapy drugs (cisplatin followed by docetaxel) thru the vein on days 1 and 22 of treatment. Group 2 (called Arm 2) will receive the chemotherapy drug, (cisplatin) thru the vein on days 1,8,22, and 29 of treatment. They also receive the chemotherapy (docetaxel) on days 1,8,15, 22, and 29.When chemotherapy is started, the patient also, receives radiation therapy, once a day, 5 days a week for about 5 weeks. Each radiation therapy treatment takes about 10 minutes. Following this there is a re-evaluation, most patients will have surgery to remove all or most of the lung cancer 4-8 weeks after completing chemotherapy or a combination of chemotherapy and radiation therapy. Surgery after the chemotherapy and radiation is done to remove any remaining cancer and to decrease the risk of the cancer returning to the lung.Then patients that received surgery, after 4-6 weeks will start the hemotherapy drug of docetaxel thru the vein every 3 weeks for 3 cycles. Patients will also receive a drug called pegfilgrastim , to help their bone marrow make new white blood cells and fight infection. Pegfilgrastim is given 24 hours after each dose of docetaxel by an injection under the skin. Patients whose cancer has progressed or who are too ill after chemotherapy or chemotherapy and radiation is finished will not have surgery. Patients are then followed at different intervals and for life. There will be physical examinations and testing done periodically while in the study according to protocol. Patients are in the study for 5 years. This study is sponsored by the Radiation Therapy Oncology Group of the American College of Radiology

Sponsoring Department: Surgery - Division of Cardiothoracic Surgery
Sponsoring Company: Radiation Therapy Oncology Group of the American College of Radiology
Investigator: Stephen R. Hazelrigg, MD
Number of other sites in trial: SIU School of Medicine; Memorial Medical Center, St. John's Hospital
Basic Eligibility Criteria: Participants must be single, newly diagnosed primary lung parenchymal lesion of State IIIA (T1-T3) with ipsilateral involved mediastinal lymph nodes measuring less than or equal to 3 cm; N2 nodes must be separate from primary tumor
Age: 18 years of age or older
Contact Person: Contact Person: Theresa Boley, RN, MSN, APN/FNP
Contact Phone: 217-545-5000
Contact Email: tboley@siumed.edu

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Updated May 10, 2006