Brain Metastases
Conditions
Keywords
Magnetic Resonance Imaging-guided Adaptive Radiotherapy
Brief summary
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)
Detailed description
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.
Interventions
RADIATIONmagnetic resonance imaging-guided adaptive radiotherapy
Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age ≥ 18 years; KPS score ≥ 60. 2. pathologically confirmed lung cancer. 3. diagnosed with brain metastases by enhanced MRI. 4. BM volume ≥ 2cm. 5. Anticipated time to survival\>3 months. 6. Treated with Unity MR-linac. 7. Good compliance; Able to stay still in supine position for 45 minutes and above.
Exclusion criteria
1. Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months. 2. Suffer from severe back pain in supine position, unable to receive Unity MR-linac. 3. Suffer from severe claustrophobia. 4. Incomplete pre-Unity image data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-cranial progression-free survival (IPFS) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate (LCR) | 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. | LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria. |
| Overall survival (OS) | From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months. | Defined as the time from the date of radiation to the date of any documented death due to any cause. |
| Objective Response Rate (ORR) | 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. | 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. |
| Disease control rate (DCR) | 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. | 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. |
| Adverse Event | AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months. | 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. |
Countries
China
Contacts
Primary ContactNan Bi, MD
Backup ContactYuchao Ma, MD
Outcome results
None listed