Prognosis of Patient Evaluated for Palliative Radiotherapy

Cancer Clinical Trial

— PROPER  

Official title:

Prospective Observational Study of the Prognosis of Patients Having Palliative Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797755
• Other study ID #: NTWC_Onc_2019
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Tuen Mun Hospital
• Contact: Shing Fung Lee, MBBS (HK), FRCR (UK)
• Phone: 852 2468 5087
• Email: leesfm[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Radiotherapy

Intervention

Radiation:
• palliative radiotherapy
Radiotherapy for palliating symptoms in stage IV cancer patients

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall Survival in the studied population	1 year
Secondary	Overall Survival in Each Indication of Palliative Radiotherapy	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
Secondary	Overall Survival by Survival Prediction Model (NRF)	Overall Survival by Survival Prediction Score using Number of Risk Factors (NRF)	3, 6, 9, 12 months
Secondary	Overall Survival by Survival Prediction Model (TEACHH)	Overall Survival by Survival Prediction Score using TEACHH Model	3, 6, 9, 12 months