CancerPROGRADNCT02312791
Prognosis of Inpatients Evaluated for Palliative Radiotherapy
An observational study of Cancer, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 362 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients evaluated for palliative Radiation Therapy
Who may be able to join
- All inpatients evaluated for palliative radiation therapy at ICESP (Instituto do Cancer do Estado de Sao Paulo)
Who cannot join
- Inpatients evaluated whose intent of treatment is curative
- Patients who are unwilling to participate in the study or unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 01246000
About this study
Official title: Observational Study of Prognosis of Inpatients Evaluated for Palliative Radiotherapy
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
- Cancer
- Keywords
- Radiation, Prognosis, Palliative Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Patients | Inpatients evaluated for palliative radiation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival in the studied population
Measured: 9 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months and 9 months
Positive Predictive Value of PPI
Positive Predictive Value of PPI to predict death at 3 weeks and 6 weeks.
Measured: 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Tsin Chih Chen, University of Sao Paulo
- Investigators
- Heloisa A Carvalho, MD PhD, Study director, University of Sao PauloAndre T Chen, MD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312791
- Sponsor's protocol ID
- NP 683/2014
- Acronym
- PROGRAD
- Status last verified
- Jan 2019
- First submitted
- 14 Oct 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
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 10335930Chow 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 19018082Weltman 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 11728693Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Prognosis of Inpatients Evaluated for Palliative Radiotherapy
- ClinicalTrials.gov ID
- NCT02312791
- Acronym / sponsor ID
- PROGRAD / NP 683/2014
- Conditions
- Cancer
- Keywords
- Radiation, Prognosis, Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Patients | – | –Inpatients evaluated for palliative radiation therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients evaluated for palliative Radiation Therapy
Key inclusion criteria (1 listed)
- All inpatients evaluated for palliative radiation therapy at ICESP (Instituto do Cancer do Estado de Sao Paulo)
Key exclusion criteria (2 listed)
- Inpatients evaluated whose intent of treatment is curative
- Patients who are unwilling to participate in the study or unwilling to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 9 months
Overall Survival in the studied population
5 secondary outcomes
Overall Survival in Each Indication of Palliative Radiotherapy
Time frame: 3 months and 9 months
Overall Survival by Palliative Prognostic Index (PPI)
Time frame: 3 months and 9 months
Overall Survival by Survival Prognostic Score (SPS)
Time frame: 3 months and 9 months
Overall Survival by Score Index for Stereotactic Radiosurgery for Brain Metastases (SIR)
Time frame: 3 months and 9 months
Positive Predictive Value of PPI
Time frame: 3 weeks and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 10335930Morita 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.
- Background: PubMed 19018082Chow 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.
- Background: PubMed 11728693Weltman 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.
- Derived from this study: PubMed 29625809Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heloisa A Carvalho, MD PhD study director
University of Sao Paulo
Andre T Chen, MD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312791, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.