Clinical trial NCT02312791: Prognosis of Inpatients Evaluated for Palliative Radiotherapy
Official title: Observational Study of Prognosis of Inpatients Evaluated for Palliative Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Radiation
Prognosis
Palliative Care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients evaluated for palliative Radiation Therapy

Brief summary: Understanding patient's prognosis is of utmost importance to determine radiotherapy's indication and dose/ fractionation. The investigators plan to conduct an observational study of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital in Brazil.


Eligibility criteria: Inclusion Criteria:

* All inpatients evaluated for palliative radiation therapy at ICESP (Instituto do Cancer do Estado de Sao Paulo)

Exclusion Criteria:

* Inpatients evaluated whose intent of treatment is curative
* Patients who are unwilling to participate in the study or unwilling to sign informed consent

Primary outcomes:
measure: Overall Survival
timeFrame: 9 months
Secondary outcomes:
measure: Overall Survival in Each Indication of Palliative Radiotherapy
timeFrame: 3 months and 9 months
measure: Overall Survival by Palliative Prognostic Index (PPI)
timeFrame: 3 months and 9 months
measure: Overall Survival by Survival Prognostic Score (SPS)
timeFrame: 3 months and 9 months
measure: Overall Survival by Score Index for Stereotactic Radiosurgery for Brain Metastases (SIR)
timeFrame: 3 months and 9 months
measure: Positive Predictive Value of PPI
timeFrame: 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
Study officials:
affiliation: University of Sao Paulo
name: Heloisa A Carvalho, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Andre T Chen, MD
role: STUDY_CHAIR
References:
citation: Morita T, Tsunoda J, Inoue S, Chihara S. The Palliative Prognostic Index: a scoring system for survival prediction of terminally ill cancer patients. Support Care Cancer. 1999 May;7(3):128-33. doi: 10.1007/s005200050242.
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: Weltman E, Salvajoli JV, Brandt RA, de Morais Hanriot R, Prisco FE, Cruz JC, de Oliveira Borges S, Lagatta M, Ballas Wajsbrot D. Radiosurgery for brain metastases: who may not benefit? Int J Radiat Oncol Biol Phys. 2001 Dec 1;51(5):1320-7. doi: 10.1016/s0360-3016(01)01696-0.
citation: Chen ATC, Mauro GP, Gabrielli F, Chaves CLG, Castro I, Vasconcelos KM, Reis M, Saraiva T, Carvalho HA. PROGRAD - An observational study of the prognosis of inpatients evaluated for palliative radiotherapy. Radiother Oncol. 2018 May;127(2):299-303. doi: 10.1016/j.radonc.2018.03.021. Epub 2018 Apr 3.