NCT05100342

Prospective Validation of a Points Score System Predicting 30-day Survival

Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 114 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, attendance to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment.

Detailed description

This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al (section 10.0) on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment. The prediction tool assigns a score from 0-20, with 20 indicating the worst survival prognosis; the investigators have designated mortality risk groups as follows: low-risk (score 0-6), intermediate-risk (score 7-13), and high-risk (score 14-20). Patient survival and quality of life will then be monitored at 30-day, 90-day, and 365-day intervals. The study will test the hypothesis that patients with a score of \>14 have a less than 20% chance of survival at 30 days. Primary Objective: 1\. To evaluate 30-day survival of patients with a score of \>14 (high-risk group) Secondary Objectives: 1. To evaluate 30-day, 90-day, and 365-day survival of patients in low-risk (score 0-6), and intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survival of patients in high-risk group (score \>14) 2. To evaluate patient-reported quality of life at the above intervals using the validated FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version)

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point score prediction tool for 30-day survival	This tool requires laboratory data including white blood cell count, neutrophil-lymphocyte ratio, blood urea nitrogen, bilirubin, albumin, lactate dehydrogenase, and red cell distribution, as well as number of attendances to the emergency room in the past 100 days, the site receiving radiation therapy, and the primary cancer type. Each data point correlates with a point value, which are tallied to generate a final score. The scores range from 0-20, with 0 giving the highest chance for survival at 30 days and 20 giving the lowest chance for survival at 30 days

Timeline

• Start date: 2022-09-12
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2021-10-29
• Last updated: 2026-01-08

Locations

3 sites across 1 country: United States