Clinical trial NCT04832672: Sequence of Radiation and Targeted Therapy in Brain Metastases
Official title: The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases
Keywords: Brain metastases
Radiotherapy
Targeted therapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-04-06
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent hypofractionated stereotactic radiotherapy planning at our institution from October 2010 to October 2020

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intracranial progression-free survival
timeFrame: 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 outcomes:
measure: Overall survival
timeFrame: 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
measure: Brain metastasis-specific survival
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
citation: Yang S, Xiao J, Liu Q, Zhang Y, Bi N, Huang X, Chen X, Wang K, Ma Y, Deng L, Wang W, Zhao R, Li J, Yi J, Wang S, Li Y. The Sequence of Intracranial Radiotherapy and Systemic Treatment With Tyrosine Kinase Inhibitors for Gene-Driven Non-Small Cell Lung Cancer Brain Metastases in the Targeted Treatment Era: A 10-Year Single-Center Experience. Front Oncol. 2021 Oct 14;11:732883. doi: 10.3389/fonc.2021.732883. eCollection 2021.