Prognosis of Inpatients Evaluated for Palliative Radiotherapy

Cancer Clinical Trial

— PROGRAD  

Official title:

Observational Study of Prognosis of Inpatients Evaluated for Palliative Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312791
• Other study ID #: NP 683/2014
• Status: Completed
• Start date: December 2014
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: January 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall Survival in the studied population	9 months
Secondary	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	3 months and 9 months
Secondary	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	3 months and 9 months
Secondary	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	3 months and 9 months
Secondary	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	3 months and 9 months
Secondary	Positive Predictive Value of PPI	Positive Predictive Value of PPI to predict death at 3 weeks and 6 weeks.	3 weeks and 6 weeks