Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT05100342

Conditions

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Point score prediction tool for 30-day survival

Study Details

Brief 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.

Conditions

Metastatic Cancer

Study ID

NCT05100342

Start date

Sep 12, 2022

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 at time of consent
2. Ability to provide written informed consent
3. Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
4. Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
5. Those patients who undergo a course of palliative radiation therapy, it is not the requirement of this study to complete that course of treatment. Those who prematurely end their course of treatment will remain eligible Note: Patients who ultimately either choose to not receive radiation or not recommended to receive radiation will remain eligible

Note: Patients who ultimately do not complete prescribed radiation will remain eligible

Exclusion Criteria:

1. Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
2. Patients who are receiving definitive/curative course of radiation therapy
3. Patients who self-report as pregnant or nursing

Study Design

Enrollment

214 participants

Anticipated

Interventions and Outcome Measures

Arms

Low-risk

Low-risk:score 0-6

Intermediate-risk

Intermediate-risk: score 7-13

High-risk

High-risk:score 14-20

Interventions

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

Primary outcome measure

  • 30-day survival of patients with a score of >14 (high-risk group) [ Time Frame: From baseline to 30 days after enrollment ]

Central Contacts and Locations

Central contacts

Jessica Anders

(317) 274-0220jemlynn@iu.edu

Locations

IU Health West

Recruiting

Avon, Indiana, United States, 46123

Contacts

Todd Foster

317-278-2546tlfoster@iu.edu

IU Health North / Schwarz Cancer Center

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Matthew Buzzell

317-274-0925matabuzz@iu.edu

Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kathy Lauer

317-962-3172klauer@iuhealth.org

More Information

Sponsor

Indiana University

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • palliative radiation
  • radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-08.