Metastatic CancerNCT05100342
Prospective Validation of a Points Score System Predicting 30-day Survival
An observational study of Metastatic Cancer, run by Indiana University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Point score prediction tool for 30-day survival
- How many people
- 214 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2022to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential patients will be identified and recruited per the recommendation of the consulting radiation oncologist at IUSCCC, IUH Methodist Hospital, Schwarz Cancer Center and IU West hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Naoyuki G Saito, MD PhD contact
United States3 sites, 3 recruiting
- Recruiting
IU Health West
Avon, Indiana, 46123
Todd Foster, 317-278-2546, tlfoster@iu.edu
- Recruiting
IU Health North / Schwarz Cancer Center
Carmel, Indiana, 46032
Matthew Buzzell, (317) 274-0925, matabuzz@iu.edu
- Recruiting
Methodist Hospital
Indianapolis, Indiana, 46202
Kathy Lauer, 317-962-3172, klauer@iuhealth.org
About this study
Official title: Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy
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.
Read the 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:
- To evaluate 30-day survival of patients with a score of >14 (high-risk group)
Secondary Objectives:
- 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)
- 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
- Being tested
- Point score prediction tool for 30-day survival
- Keywords
- palliative radiation, radiation therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point score prediction tool for 30-day survivalDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Low-risk | Low-risk:score 0-6 Receives: Diagnostic Test: Point score prediction tool for 30-day survival | |
| Intermediate-risk | Intermediate-risk: score 7-13 Receives: Diagnostic Test: Point score prediction tool for 30-day survival | |
| High-risk | High-risk:score 14-20 Receives: Diagnostic Test: Point score prediction tool for 30-day survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 30 days after enrollment
Secondary outcomes (2)
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.
Measured: 30 days, 90 days and 365 days after enrollment
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
Measured: Baseline, 30 days, 90 days and 365 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start12 Sep 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoyuki G. Saito, M.D., Ph.D., Indiana University
- Investigators
- Naoyuki Saito, MD PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100342
- Sponsor's protocol ID
- CTO-IUSCCC-0763
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy
- ClinicalTrials.gov ID
- NCT05100342
- Acronym / sponsor ID
- CTO-IUSCCC-0763
- Conditions
- Metastatic Cancer
- Keywords
- palliative radiation, radiation therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate 30-day survival of patients with a score of >14 (high-risk group)
Secondary Objectives:
- 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)
- 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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk | – | Diagnostic Test: Point score prediction tool for 30-day survivalLow-risk:score 0-6 |
| Intermediate-risk | – | Diagnostic Test: Point score prediction tool for 30-day survivalIntermediate-risk: score 7-13 |
| High-risk | – | Diagnostic Test: Point score prediction tool for 30-day survivalHigh-risk:score 14-20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential patients will be identified and recruited per the recommendation of the consulting radiation oncologist at IUSCCC, IUH Methodist Hospital, Schwarz Cancer Center and IU West hospital.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point score prediction tool for 30-day survivalThis 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 | Diagnostic test | High-risk, Intermediate-risk, Low-risk |
Primary outcome
30-day survival of patients with a score of >14 (high-risk group)
Time frame: From baseline to 30 days after enrollment
The percentage of patients with a score of >14 who are living at 30 days following enrollment
2 secondary outcomes
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
Time frame: 30 days, 90 days and 365 days after enrollment
Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days
Time frame: Baseline, 30 days, 90 days and 365 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naoyuki G Saito, MD PhD contact
Naoyuki Saito, MD PhD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Anders ((317) 274-0220, jemlynn@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.