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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM patients receiving MRIgART | For it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging-guided adaptive radiotherapy | Radiation | Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions) |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate (LCR) | LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from Cancer Institute and Hospital, Chinese Academy of Medical Sciences
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Bi, MD | Contact | 8601087788799 | binan_email@163.com | |
| Yuchao Ma, MD | Contact | mycbyts@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Bi, MD | Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Peking Union Medical College | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Overall survival (OS) |
Defined as the time from the date of radiation to the date of any documented death due to any cause. |
| 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. | 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. | 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. | AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |