Sponsor: NRG
Sponsor Study ID: NRG-CC014
Study Title: NRG-CC014 Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (Preempt)
CTO #: 104213
NCT Number: NCT06745024
Phase: III
Protocol Type: Supportive Care
Age Group: Adults
Disease Sites: Anus; Bladder; Bones and Joints; Breast; Cervix Uteri; Colon; Kidney; Liver; Lung; Ovary; Pancreas; Prostate; Rectum; Small Intestine; Stomach
Study Objectives: 1. OBJECTIVES 1.1 Primary Objective To determine whether prophylactic radiation therapy (RT) to high-risk asymptomatic bone metastases decreases the occurrence of skeletal-related events (SREs), including pathologic fracture, spinal cord compression, and surgery to bone (not including palliative radiation for pain only), compared to standard of care (SOC). 1.2 Secondary Objectives 1.2.1 To compare overall survival (OS) between study arms. 1.2.2 To compare occurrence of any SREs (including RT for palliation of pain) among enrolled bone metastasis(es) between study arms. 1.2.3 To compare occurrence of hospitalizations related to any SREs in enrolled bone metastasis(es) between study arms. 1.2.4 To compare pain-related quality of life (QOL) between study arms. 1.2.5 To characterize adverse events of RT and compare to SOC. 1.3 Exploratory Objectives 1.3.1 To evaluate overall QOL, functional status, and quality-adjusted life years between study arms. 1.3.2 To evaluate any hospitalizations (from any cause) between study arms. 1.3.3 To characterize differences in primary and secondary endpoints between study arms (a) among the represented racial and ethnic groups (e.g. Black, White, Hispanic/Latino, Asian/Pacific Islander, and Native American),(b) by sex, and (c) by health-related social needs. 1.3.4 To evaluate the heterogeneity of radiation treatment effect based on cancer-related factors (histology, criteria indicating high-risk for SRE), treatment-related factors (bone modifying agent use, radiation dose/technique), and patient demographic factors (age, sex, race, ethnicity, and health-related social needs).