Brain MetastasesTBMPPFNCT05609162
Treatments for Brain Metastases With Poor Prognostic Factors
An observational study of Brain Metastases, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Metastases
- What is being tested?
- neurosurgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 20 Nov 2024
- 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: 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.
Who may be able to join
- Evidence of pathological diagnosis of primary tumor;
- Brain metastases confirmed by enhanced magnetic resonance imaging;
- Complete clinical information
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Brain Metastases
- Being tested
- neurosurgical resection
- Keywords
- Brain Metastases, local treatments, systemic treatments, poor prognosis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurosurgical resectionProcedure or surgery
Also called radiation, chemotherapy, target therapy
neurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: neurosurgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival time
Measured: 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
Measured: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Dec 2022 (estimated)
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Hospital of Guangxi Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Yonggao Mou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609162
- Sponsor's protocol ID
- B2020-218-01
- Acronym
- TBMPPF
- Status last verified
- Dec 2022
- First submitted
- 2 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We decided not to share the IPD because the study involved a lot of people's privacy
Publications
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.
PubMed 41531790
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local and Systemic Treatments in Brain Metastases With Poor Prognostic Factors: Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05609162
- Acronym / sponsor ID
- TBMPPF / B2020-218-01
- Conditions
- Brain Metastases
- Keywords
- Brain Metastases, local treatments, systemic treatments, poor prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Cancer Hospital of Guangxi Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Guangxi Medical University
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 8 Nov 2022 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| local treatment group vs non-local treatment group | – | Procedure: neurosurgical resectionParticipants 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 |
| 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 | – | Procedure: neurosurgical resectionParticipants 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 |
| local treatment group vs local treatment+systemic treatment group | – | Procedure: neurosurgical resectionParticipants 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 |
| systemic treatment group vs local treatment+systemic treatment group | – | Procedure: neurosurgical resectionParticipants 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 |
| local treatment+systemic treatment group vs non-local treatment+systemic treatment group | – | Procedure: neurosurgical resectionParticipants underwent local treatment plus systemic treatment were divided into local treatment+systemic treatment group or otherwise into non-local treatment+systemic treatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Evidence of pathological diagnosis of primary tumor;
- Brain metastases confirmed by enhanced magnetic resonance imaging;
- Complete clinical information
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurosurgical resectionAlso: radiation, chemotherapy, target therapyneurosurgical resection, stereotactic radiosurgery (SRS), whole brain radiotherapy(WBRT), EGFR target drugs, Immune checkpoint inhibitors，cisplatin, temozolomide | Procedure or surgery | local treatment group vs local treatment+systemic treatment group, local treatment group vs non-local treatment group, local treatment group vs systemic treatment group, local treatment+systemic treatment group vs non-local treatment+systemic treatment group, systemic treatment group vs local treatment+systemic treatment group |
Primary outcome
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
1 secondary outcome
PFS
Time frame: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 41531790Li 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.
- Individual participant dataSharing planned: No. We decided not to share the IPD because the study involved a lot of people's privacy
Related trials for Brain Metastases
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Metastases, run by Sun Yat-sen University at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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 China. 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?
Results are not available in the source record.
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?
OS (time frame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 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 NCT05609162, which also lists 1 linked publication.
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 Dec 2022.