This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)
All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.
Study Type
OBSERVATIONAL
Enrollment
20
Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)
Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
RECRUITINGIntra-cranial progression-free survival (IPFS)
Defined as the time from date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first.
Time frame: From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.
Local control rate (LCR)
LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.
Time frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Overall survival (OS)
Defined as the time from the date of radiation to the date of any documented death due to any cause.
Time frame: From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.
Objective Response Rate (ORR)
The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Disease control rate (DCR)
DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Adverse Event
The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by EORTC/RTOG Radiation Grading System Criteria and CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
Time frame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.