CompletedNCT02312791PROGRADUpdated Jan 15, 2019

Prognosis of Inpatients Evaluated for Palliative Radiotherapy

An observational study in Cancer, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by University of Sao Paulo · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 362
Sex: All

Study 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.

Conditions studied

Cancer

Keywords

Radiation
Prognosis
Palliative Care

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Inpatients evaluated for palliative Radiation Therapy

Inclusion criteria

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

Exclusion criteria

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 362 participants (actual)
Patient registry: No

Groups and cohorts

Palliative Patients
Inpatients evaluated for palliative radiation therapy.

What researchers measure

Primary outcomes

Overall Survival
Overall Survival in the studied population
Time frame: 9 months

Secondary outcomes

Overall Survival in Each Indication of Palliative Radiotherapy
Overall Survival in Each Indication of Palliative Radiotherapy. The indication will be as follow: * spinal cord compression * brain metastases * tumor bleeding * tumoral mass * Oncologic Pain * Superior Vena Cava Syndrome/ Airway compression
Time frame: 3 months and 9 months
Overall Survival by Palliative Prognostic Index (PPI)
Patients will be divided into 3 subgroups according to the PPI. Survival differences between the different subgroups will be compared and analyzed
Time frame: 3 months and 9 months
Overall Survival by Survival Prognostic Score (SPS)
Patients will be divided into 3 subgroups according to the SPS. Survival differences between the different subgroups will be compared and analyzed
Time frame: 3 months and 9 months
Overall Survival by Score Index for Stereotactic Radiosurgery for Brain Metastases (SIR)
Patients will brain metastases will be divided into 3 subgroups according to SIR. They will be divided into SIR 0-3; 4-7;8-10. Survival differences between the different subgroups will be compared and analyzed
Time frame: 3 months and 9 months
Positive Predictive Value of PPI
Positive Predictive Value of PPI to predict death at 3 weeks and 6 weeks.
Time frame: 3 weeks and 6 weeks

Study locations

1 site

Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
Sao Paulo, 01246000, Brazil

References and documents

Publications

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. PubMed 10335930 ↗
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. PubMed 19018082 ↗
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. PubMed 11728693 ↗
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. PubMed 29625809 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02312791
Lead sponsor: University of Sao Paulo
Responsible party: Andre Tsin Chih Chen (MD, University of Sao Paulo) — Principal investigator
First posted: Dec 9, 2014
Start date: Dec 2014
Primary completion: Sep 2017
Completion: Jan 2019
Last update: Jan 15, 2019

Study contacts

Heloisa A Carvalho, MD PhD

study director · University of Sao Paulo

Andre T Chen, MD

study chair · University of Sao Paulo

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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