Treatments for Brain Metastases With Poor Prognostic Factors (TBMPPF)

December 13, 2022 updated by: Yonggao Mou, Sun Yat-sen University

Effects of Local and Systemic Treatments in Brain Metastases With Poor Prognostic Factors: Multicenter Retrospective Study

The goal of this observational study is to learn about treatments in brain metastases with poor prognostic factors. The main questions it aims to answer are:

  • What kind of local treatment provides a survival benefit for patients with poor prognostic factors?
  • What kind of systemic treatment provides a survival benefit for patients with poor prognostic factors?
  • Will the combination of local treatment and systemic treatment provide a survival benefit for patients with poor prognostic factors?

Participants will be asked to provide personal information about their living status, symptoms, and disease control during the follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510006
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospital clients from Sun Yat-sen University Cancer Center, Guangxi Medical University Cancer Hospital, The People's Hospital Of Guangxi Zhuang Autonomous Region, and the First Affiliated Hospital of Guangxi Medical University will be selected.

Description

Inclusion Criteria:

  1. Evidence of pathological diagnosis of primary tumor;
  2. Brain metastases confirmed by enhanced magnetic resonance imaging;
  3. Complete clinical information

Exclusion Criteria:

  1. Survival time less than 30 days;
  2. If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery;
  3. Incomplete clinical data;
  4. Patients with 2 or more types of tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
local treatment group vs non-local treatment group
Participants underwent local treatments such as surgical resection or radiotherapy or surgical resection plus radiotherapy were divided into local treatment group or otherwise into non-local treatment group
Procedure: neurosurgical resection
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
Other Names:
  • radiation
  • chemotherapy
  • target therapy
systemic treatment group vs non-systemic treatment group
Participants underwent systemic treatments such as chemotherapy or target therapy or chemotherapy plus target therapy were divided into systemic treatment group or otherwise into non-systemic treatment group
local treatment group vs systemic treatment group
Participants underwent local treatments such as surgical resection or radiotherapy or surgical resection plus radiotherapy were divided into local treatment group; Participants underwent systemic treatments such as chemotherapy or target therapy or chemotherapy plus target therapy were divided into systemic treatment group
Procedure: neurosurgical resection
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
Other Names:
  • radiation
  • chemotherapy
  • target therapy
local treatment group vs local treatment+systemic treatment group
Participants underwent local treatments such as surgical resection or radiotherapy or surgical resection plus radiotherapy were divided into local treatment group; Participants underwent local treatment plus systemic treatment were divided into local treatment+systemic treatment group
Procedure: neurosurgical resection
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
Other Names:
  • radiation
  • chemotherapy
  • target therapy
systemic treatment group vs local treatment+systemic treatment group
Participants underwent systemic treatments such as chemotherapy or target therapy or chemotherapy plus target therapy were divided into systemic treatment group; Participants underwent local treatment plus systemic treatment were divided into local treatment+systemic treatment group
Procedure: neurosurgical resection
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
Other Names:
  • radiation
  • chemotherapy
  • target therapy
local treatment+systemic treatment group vs non-local treatment+systemic treatment group
Participants underwent local treatment plus systemic treatment were divided into local treatment+systemic treatment group or otherwise into non-local treatment+systemic treatment group
Procedure: neurosurgical resection
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
Other Names:
  • radiation
  • chemotherapy
  • target therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months
Overall survival time
From date of first follow-up until the date of documented death from any cause, assessed up to 120 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Progression-free survival time
From date of first follow-up until the date of first documented progression, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Hospital of Guangxi Medical University
First Affiliated Hospital of Guangxi Medical University
Guangxi Zhuang Autonomous Region People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2020-218-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We decided not to share the IPD because the study involved a lot of people's privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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