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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100342
• Other study ID #: CTO-IUSCCC-0763
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Indiana University
• Contact: Nikki Barrow
• Phone: 317-944-0260
• Email: nrbarrow[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 at time of consent

2. Ability to provide written informed consent

3. Metastatic cancer diagnosis referred to Radiation Oncology for palliative radiation therapy

4. Patients, as assessed by the radiation oncologist, who present with symptoms secondary to cancer that can be palliated by radiation therapy 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 receiving definitive/curative course of radiation therapy

3. Patients who self-report as pregnant or nursing females are excluded from this study.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
United States	IU Health West	Avon	Indiana
United States	IU Health North / Schwarz Cancer Center	Carmel	Indiana
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Indiana University Health Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day survival of patients with a score of >14 (high-risk group)	The percentage of patients with a score of >14 who are living at 30 days following enrollment	From baseline to 30 days after enrollment
Secondary	The percentage of patients in each risk group (low, intermediate, and high) who are living at 30 days, 90 days, and 365 days following enrollment	Review of medical records.	30 days, 90 days and 365 days after enrollment
Secondary	Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days	Using the FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version	Baseline, 30 days, 90 days and 365 days after enrollment