RecruitingNCT05100342

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


Sponsor

Indiana University

Enrollment

214 participants

Start Date

Sep 12, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥ 18 at time of consent
  • Ability to provide written informed consent
  • Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
  • Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
  • 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 Criteria3

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

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Interventions

DIAGNOSTIC_TESTPoint 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


Locations(3)

IU Health West

Avon, Indiana, United States

IU Health North / Schwarz Cancer Center

Carmel, Indiana, United States

Methodist Hospital

Indianapolis, Indiana, United States

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NCT05100342


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