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

Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
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.NCT03799523Eva Galvan MD

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.NCT06479135Zohra Nooruddin MD

Clinical Trial

A Phase II multicenter, open-label, single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase – Chronic Myelogenous Leukemia (ASC2ESCALATE) (CTMS# 23-0101)

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning, or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

APOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationAPOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationThis is a non-randomized biomarker study with the aim to evaluate the relationship between APOBEC3B (A3B) expression in primary head and neck cancers (HNC), anus, and cervix tumors and pathologic response to definitive chemoradiation therapy.ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger).ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvShortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvTo learn about the effects of shorter RNI regimens in patients with breast cancer who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.NCT07076485Shraddha Dalwadi, MD, MBA