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Completed

NCT Number: NCT04832672

Sequence of Radiation and Targeted Therapy in Brain Metastases

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.

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Key information

Conditions

The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intracranial progression-free survival

    Time frame: 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

    The survival time of patients before any intracranial progression

Secondary outcomes

  1. Overall survival

    Time frame: 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

    The survival time of patients

  2. Brain metastasis-specific survival

    Time frame: 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

    The survival time of patients dead from brain metastases

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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