R0937 Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Primary Objective:To determine the 1-year overall median survival rate in patients with ED-SCLC with the administration of PCI alone versus PCI with consolidation extracranial RT following platinumbased chemotherapy. Secondary Objectives: 1. To compare treatment-related adverse events; 2. To evaluate patterns of failure; 3. To compare the time to first failure; 4. To evaluate the percentage of the planned radiation dose given to each site.
1. Diagnosis of extensive disease small cell lung cancer 2. Zubrod Performance Status 0-2 3. No central nervous system metastases 4. Recent completion of 4-6 cycles of platinum based chemotherapy
If you agree to be in this study, we will ask you to do the following things: All participants will have completed chemotherapy before they participate in this study. You will be "randomizedâ?? into one of the 2 study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in one of the 2 groups If you are in group 1 (often called â??Arm 1â??), you will receive radiation to the brain daily, Monday-Friday, for 2 weeks. If you are in group 2 (often called â??Arm 2â??), you will receive radiation to the brain daily, Monday-Friday, for 2 weeks and radiation to the chest and other sites of cancer that did not completely respond to the chemotherapy. You and your doctor will discuss whether you will have radiation to the chest and other sites on the same days as the brain radiation or if you will receive radiation to the chest and other sites after the brain radiation is finished. If you receive radiation to the chest and other sites after brain radiation is finished, you will have treatment daily, Monday-Friday, for an additional 2-3 weeks. Radiation therapy for all patients will take no longer than 5 weeks.
05/25/2013 04:02 AM