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Status unknownNCT05609162TBMPPFUpdated Dec 15, 2022

Treatments for Brain Metastases With Poor Prognostic Factors

An observational study in Brain Metastases, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
2,000
Sex
All
01

Study summary

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.

02

Conditions studied

  • Brain Metastases

Keywords

  • Brain Metastases
  • local treatments
  • systemic treatments
  • poor prognosis
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 121 across 593 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Procedureneurosurgical resection

    neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors,cisplatin, temozolomide

    Also known as: radiation, chemotherapy, target therapy

06

What researchers measure

Primary outcomes

  1. OS

    Overall survival time

    Time frame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months

Secondary outcomes

  1. PFS

    Progression-free survival time

    Time frame: From date of first follow-up until the date of first documented progression, assessed up to 120 months

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510006, China
08

References and documents

Individual participant data

Plan to share: No — We decided not to share the IPD because the study involved a lot of people's privacy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05609162
Lead sponsor
Sun Yat-sen University
Collaborators
Cancer Hospital of Guangxi Medical University, Guangxi Zhuang Autonomous Region People's Hospital, First Affiliated Hospital of Guangxi Medical University
Responsible party
Yonggao Mou (Department of Neurosurgery, Sun Yat-sen University) — Principal investigator
First posted
Nov 8, 2022
Start date
Dec 15, 2022 (estimated)
Primary completion
Nov 20, 2023 (estimated)
Completion
Nov 20, 2024 (estimated)
Last update
Dec 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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