Prognosis of Patient Evaluated for Palliative Radiotherapy (PROPER)

January 7, 2019 updated by: Shing Fung Lee, Tuen Mun Hospital

Prospective Observational Study of the Prognosis of Patients Having Palliative Radiotherapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
        • Contact:
          • Shing Fung Lee, MBBS (HK), FRCR (UK)
          • Phone Number: 852 2468 5087
          • Email: leesfm@ha.org.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Palliative Cancer Patients
Stage IV cancer patients evaluated for palliative radiotherapy.
Radiation: palliative radiotherapy
Radiotherapy for palliating symptoms in stage IV cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year
Overall Survival in the studied population
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival in Each Indication of Palliative Radiotherapy
Time Frame: 3, 6, 9, 12 months

Indications of Palliative Radiotherapy:

The indication will be as follow:

spinal cord compression brain metastases tumor bleeding tumoral mass Cancer pain Superior Vena Cava Syndrome/ Airway compression
3, 6, 9, 12 months
Overall Survival by Survival Prediction Model (NRF)
Time Frame: 3, 6, 9, 12 months
Overall Survival by Survival Prediction Score using Number of Risk Factors (NRF)
3, 6, 9, 12 months
Overall Survival by Survival Prediction Model (TEACHH)
Time Frame: 3, 6, 9, 12 months
Overall Survival by Survival Prediction Score using TEACHH Model
3, 6, 9, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Investigators

  • Principal Investigator: Shing Fung Lee, MBBS (HK), FRCR (UK), Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NTWC_Onc_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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