Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET.

BACKGROUND: Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. METHODS: This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. DISCUSSION: This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

An evaluation of the accuracy of small-area demographic estimates of population at risk and its effect on prevalence statistics.

Demographic estimates of population at risk often underpin epidemiologic research and public health surveillance efforts. In spite of their central importance to epidemiology and public-health practice, little previous attention has been paid to evaluating the magnitude of errors associated with such estimates or the sensitivity of epidemiologic statistics to these effects. In spite of the well-known observation that accuracy in demographic estimates declines as the size of the population to be estimated decreases, demographers continue to face pressure to produce estimates for increasingly fine-grained population characteristics at ever-smaller geographic scales. Unfortunately, little guidance on the magnitude of errors that can be expected in such estimates is currently available in the literature and available for consideration in small-area epidemiology. This paper attempts to fill this current gap by producing a Vintage 2010 set of single-year-of-age estimates for census tracts, then evaluating their accuracy and precision in light of the results of the 2010 Census. These estimates are produced and evaluated for 499 census tracts in New Mexico for single-years of age from 0 to 21 and for each sex individually. The error distributions associated with these estimates are characterized statistically using non-parametric statistics including the median and 2.5th and 97.5th percentiles. The impact of these errors are considered through simulations in which observed and estimated 2010 population counts are used as alternative denominators and simulated event counts are used to compute a realistic range fo prevalence values. The implications of the results of this study for small-area epidemiologic research in cancer and environmental health are considered.