Genetics & Biology of Liver Tumorigenesis in ChildrenGenetics & Biology of Liver Tumorigenesis in ChildrenThe overall goals of this Multi-Investigator Research Proposal is to further the understanding of the development and identify prognostic characteristics of liver tumors in children, particularly hepatoblastoma and its variants through a combined genomic and molecular pathology approach.ClinicalTrials.gov registration not requiredGail Tomlinson MD, PhD

Genetic Epidemiology of Breast and Ovarian CancersGenetic Epidemiology of Breast and Ovarian CancersA research study about factors that might increase the chance of getting breast and ovarian cancers. Eligible: female 18-80 yr old; diagnosed with breast cancer under age 50; diagnosed with ovarian cancer at any age; strong family history of breast and/or ovarian cancer.ClinicalTrials.gov registration not requiredGail Tomlinson MD, PhD

NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES NRG-BN013 is an unblinded, randomized phase III trial to determine if the time to local failure is significantlylonger with FSRS compared to SRS in patients with intact brain metastasis.NCT06500455Eva Galvan MD

Phase III Randomized Study Testing Non-inferiority of Short-course Ultra-hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) For Stage II-IIIB, Extremity, Resectable Soft Tissue SarcomaPhase III Randomized Study Testing Non-inferiority of Short-course Ultra-hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) For Stage II-IIIB, Extremity, Resectable Soft Tissue SarcomaWe propose a clinical trial comparing standard radiation (RT-25) to ultra-hypofractionated radiation (UHRT-5). If negative, this trial would stop participants from being treated, as many are, with an inferior regimen. If positive, this trial would establish a new standard of careClinicalTrials.gov registration not requiredEva Galvan MD

Clinical Trial

Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy

The first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator's patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoA Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoThis is a Phase 3 open-label, active-control, 2:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as ‘the investigational arm’) vs pembrolizumab alone (referred to as ‘the control arm’) in immune checkpoint inhibitor (ICI) naïve subjects with first line unresectable recurrent and/or metastatic (R/M) HPV16-positive HNSCC with a CPS ≥ 1.NCT06790966Devi Meyyappan MD