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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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

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
Intervention / Treatment
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

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

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

Sun Yat-sen University

Collaborators

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)

December 15, 2022

Primary Completion (Anticipated)

November 20, 2023

Study Completion (Anticipated)

November 20, 2024

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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