NCT03797755

Brief Summary

Many patients with incurable cancer will receive palliative oncological treatment before their death, and radiotherapy (RT) is an important element of this. The aim of palliative RT is to alleviate symptoms and improve quality of life. An accurate and practical survival prediction model for metastatic cancer patient receiving palliative RT can assist the decision making (ranging from best supportive treatment alone for expected short survival, to dose escalation for potential better disease control). The available survival prediction models (such Survival Prediction Score using Number of Risk Factors by Chow et al and TEACHH model) have been developed in the Western world. We therefore perform a prospective observational study 1) to assess the overall survival of patients evaluated for palliative RT at a tertiary hospital in Hong Kong, and 2) to validate the prognostic score systems in our population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 7, 2019

Last Update Submit

January 7, 2019

Conditions

Keywords

survivalcancerpalliativeradiotherapyprognosis

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall Survival in the studied population

    1 year

Secondary Outcomes (3)

  • Overall Survival in Each Indication of Palliative Radiotherapy

    3, 6, 9, 12 months

  • Overall Survival by Survival Prediction Model (NRF)

    3, 6, 9, 12 months

  • Overall Survival by Survival Prediction Model (TEACHH)

    3, 6, 9, 12 months

Study Arms (1)

Palliative Cancer Patients

Stage IV cancer patients evaluated for palliative radiotherapy.

Radiation: palliative radiotherapy

Interventions

Radiotherapy for palliating symptoms in stage IV cancer patients

Palliative Cancer Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stage IV cancer patients evaluated for palliative radiotherapy in Tuen Mun Hospital

You may qualify if:

  • All adult patients with stage IV cancer who are referred for palliative RT in Tuen Mun Hospital, including both inpatients and outpatients.

You may not qualify if:

  • Patients who have received palliative RT before (i.e. not the first course palliative RT), have non-metastatic disease, are misclassified as palliative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun

Hong Kong, Hong Kong

RECRUITING

Related Publications (7)

  • Chow E, Harth T, Hruby G, Finkelstein J, Wu J, Danjoux C. How accurate are physicians' clinical predictions of survival and the available prognostic tools in estimating survival times in terminally ill cancer patients? A systematic review. Clin Oncol (R Coll Radiol). 2001;13(3):209-18. doi: 10.1053/clon.2001.9256.

    PMID: 11527298BACKGROUND
  • Christakis NA, Lamont EB. Extent and determinants of error in doctors' prognoses in terminally ill patients: prospective cohort study. BMJ. 2000 Feb 19;320(7233):469-72. doi: 10.1136/bmj.320.7233.469.

    PMID: 10678857BACKGROUND
  • Gripp S, Mjartan S, Boelke E, Willers R. Palliative radiotherapy tailored to life expectancy in end-stage cancer patients: reality or myth? Cancer. 2010 Jul 1;116(13):3251-6. doi: 10.1002/cncr.25112.

    PMID: 20564632BACKGROUND
  • Chow E, Abdolell M, Panzarella T, Harris K, Bezjak A, Warde P, Tannock I. Predictive model for survival in patients with advanced cancer. J Clin Oncol. 2008 Dec 20;26(36):5863-9. doi: 10.1200/JCO.2008.17.1363. Epub 2008 Nov 17.

    PMID: 19018082BACKGROUND
  • Peppercorn JM, Smith TJ, Helft PR, Debono DJ, Berry SR, Wollins DS, Hayes DM, Von Roenn JH, Schnipper LE; American Society of Clinical Oncology. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J Clin Oncol. 2011 Feb 20;29(6):755-60. doi: 10.1200/JCO.2010.33.1744. Epub 2011 Jan 24.

    PMID: 21263086BACKGROUND
  • Chow E, James JL, Hartsell W, Scarantino CW, Ivker R, Roach M III, Suh JH, Demas W, Konski A, Bruner DW. Validation of a Predictive Model for Survival in Patients With Advanced Cancer: Secondary Analysis of RTOG 9714. World J Oncol. 2011 Aug;2(4):181-190. doi: 10.4021/wjon325w. Epub 2011 Aug 24.

    PMID: 29147245BACKGROUND
  • Krishnan MS, Epstein-Peterson Z, Chen YH, Tseng YD, Wright AA, Temel JS, Catalano P, Balboni TA. Predicting life expectancy in patients with metastatic cancer receiving palliative radiotherapy: the TEACHH model. Cancer. 2014 Jan 1;120(1):134-41. doi: 10.1002/cncr.28408. Epub 2013 Oct 2.

    PMID: 24122413BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Shing Fung Lee, MBBS (HK), FRCR (UK)

    Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shing Fung Lee, MBBS (HK), FRCR (UK)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Specialist

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Demographic data, and the information required for the prognostic scores will be extracted (e.g. presence of liver metastasis). Also data on the date of birth and death, sex, primary cancer. Data on the primary site of disease were coded using International Classification of Disease version 9. Personal identifier will be deleted to protect patient confidentiality.

Shared Documents
ANALYTIC CODE
Time Frame
After publication.

Locations