NCT05609162

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

November 2, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

Brain Metastaseslocal treatmentssystemic treatmentspoor prognosis

Outcome Measures

Primary Outcomes (1)

  • OS

    Overall survival time

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

Secondary Outcomes (1)

  • PFS

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

Study Arms (6)

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

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

Also known as: radiation, chemotherapy, target therapy
local treatment group vs local treatment+systemic treatment grouplocal treatment group vs non-local treatment grouplocal treatment group vs systemic treatment grouplocal treatment+systemic treatment group vs non-local treatment+systemic treatment groupsystemic treatment group vs local treatment+systemic treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Evidence of pathological diagnosis of primary tumor;
  • Brain metastases confirmed by enhanced magnetic resonance imaging;
  • Complete clinical information

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510006, China

Location

Related Publications (1)

  • Li A, Feng D, Liu C, Huang C, Li T, Wei D, Wei F, Shen M, Qin C, Deng S, Liang H, Mo P, Dong M, Yu Y, Liang L. Prognostic Analysis of Lung Cancer With Brain Metastases in Elderly Patients: A Multicenter Retrospective Study. Aging Med (Milton). 2025 Dec 31;8(6):585-591. doi: 10.1002/agm2.70060. eCollection 2025 Dec.

MeSH Terms

Conditions

Brain Neoplasms

Interventions

RadiationDrug Therapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical PhenomenaTherapeutics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurosurgery

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

December 15, 2022

Primary Completion

November 20, 2023

Study Completion

November 20, 2024

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

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

Locations