Sequence of Radiation and Targeted Therapy in Brain Metastases

The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases Clinical Trial

Official title:

The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832672
• Other study ID #: NCC-005269
• Status: Completed
• Start date: October 1, 2010
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators conducted a single institutional, retrospective cohort study to demonstrate the appropriate treatment strategy of upfront intracranial radiotherapy or upfront targeted therapy in patients with brain metastases, including an assessment of its feasibility and toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Had histologically proven primary cancer.
• Had newly diagnosed brain metastases in contrast-enhanced MRI.
• Brain metastases focus should be measurable.
• All the patients should safely receive radiotherapy and/or systematic tyrosine kinase inhibitors.
• Karnofsky performance score (KPS) =60 or KPS =40, but only caused by brain metastases.

Exclusion Criteria:

• Patients with prior intracranial local treatments, such as surgery and radiotherapy without dose prescription in detail
• Patients with leptomeningeal metastases at first diagnosis.
• Had synchronous or metachronous malignancies that might affect survival.
• Had severe systemic diseases, abnormal conditions that might lead to incoordinate behavior during the implementation of clinical measures.
• Had incomplete sociodemographic and/or clinicopathologic baseline data

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial progression-free survival	The survival time of patients before any intracranial progression	The interval from the start of initial intracranial treatment to first documented intracranial progression, or date of death from any cause, whichever came first, assessed up to 3 to 5 years
Secondary	Overall survival	The survival time of patients	The time from the date of initial intracranial treatment until death from any cause or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years
Secondary	Brain metastasis-specific survival	The survival time of patients dead from brain metastases	The interval from the start of initial intracranial treatment to death from brain metastases or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years