Clinical trial NCT03797755: Prognosis of Patient Evaluated for Palliative Radiotherapy
Official title: Prospective Observational Study of the Prognosis of Patients Having Palliative Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Radiotherapy
Keywords: survival
cancer
palliative
radiotherapy
prognosis
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage IV cancer patients evaluated for palliative radiotherapy in Tuen Mun Hospital

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival in Each Indication of Palliative Radiotherapy
timeFrame: 3, 6, 9, 12 months
measure: Overall Survival by Survival Prediction Model (NRF)
timeFrame: 3, 6, 9, 12 months
measure: Overall Survival by Survival Prediction Model (TEACHH)
timeFrame: 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
Study officials:
affiliation: Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong
name: Shing Fung Lee, MBBS (HK), FRCR (UK)
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1053/clon.2001.9256.
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. doi: 10.1136/bmj.320.7233.469.
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.
citation: 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.
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.
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.
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.