Treatments for Brain Metastases With Poor Prognostic Factors

Brain Metastases Clinical Trial

— TBMPPF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05609162
• Other study ID #: B2020-218-01
• Status: Enrolling by invitation
• Start date: December 15, 2022
• Est. completion date: November 20, 2024

Study information

• Verified date: December 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: November 20, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Guangxi Medical University, First Affiliated Hospital of Guangxi Medical University, Guangxi Zhuang Autonomous Region People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS	Progression-free survival time	From date of first follow-up until the date of first documented progression, assessed up to 120 months