Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
NRG Oncology
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04804644
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.
Intervention
Memantine Hydrochloride, Neurocognitive Assessment, Stereotactic Radiosurgery, Whole-Brain Radiotherapy
Condition
Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Investigators
Vinai Gondi, Christina K. Cramer, Bryan A. Faller, Samir Narayan, Jay W. Carlson, Michael D. Mix, Tyler Gunter, Joel Grow, Kalika P. Sarma, Terence T. Sio, Timothy V. Waxweiler, Mark V. Mishra, Jack J. Hong, Rajesh Bajaj, Charlotte Rivers, Andrew J. Huang, Kristin A. Higgins, Gaurav Marwaha, Steven J. Chmura, Kimberley S. Mak, Kyle Wang, Prashant Vempati, Rodney E. Wegner, Andrew M. Baschnagel, Gregory A. Masters, Gregory A. Azzam, Gena H. Volas-Redd, Victor T. Lin, John P. Mastandrea, Zeinab Abou Yehia, Yan Ji, John M. Schallenkamp, Yuhchyau Chen, Evan Thomas, Timothy D. Moore, Nimisha Deb, Fiori Alite, Wenyin Shi, Timothy J. Harris, Collin D. Driscoll, Site Public Contact, Thomas Hunter, Anuj Goenka, Joseph J. Merchant, Vijayananda Kundapur, Lindsay L. Puckett, Daniel Almquist, Christin A. Knowlton, Taskia Mir