MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04946019|
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Combination Product: Unity-based MR-Linac guided FSRT||Phase 2|
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.
Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine. The primary end point is 1-year intracranial progression-free survival. The secondary end points are objective response rate, 1-y PFS, 1-y OS, perilesional edema of brain metastases, quality of life, safety of treatment, dose coverage of targets and dose to normal organs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Phase II Study of MR-Linac Guided Adaptive Fractionated Stereotactic Radiotherapy for Brain Metastases From Non-small Cell Lung Cancer|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||June 1, 2023|
Experimental: MR-Linac Guided Adaptive FSRT
Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
Combination Product: Unity-based MR-Linac guided FSRT
The FSRT was delivered using the Unity-based MR-Linac treatment machine, with a total dose of 30Gy in 5 fractions.
- 1-year intracranial progression-free survival [ Time Frame: 1 year ]
- Objective response rate [ Time Frame: 2 months ]
- 1-year progression-free survival [ Time Frame: 1 year ]
- 1-year overall survival [ Time Frame: 1 year ]
- Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI [ Time Frame: 1 year ]
- Quality of life evaluated by EORTC quality of life questionnaire [ Time Frame: 1 year ]
- Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0 [ Time Frame: 1 year ]
- Dose coverage to targets [ Time Frame: 2 months ]
- Dose to normal organs [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04946019
|Contact: Daquan Wang, M.Dfirstname.lastname@example.org|
|Contact: Bo Qiu, M.Demail@example.com|
|Guangzhou, Guangdong, China, 510060|
|Contact: Hui Liu, Prof. +86-020-87343031 firstname.lastname@example.org|
|Principal Investigator:||Hui Liu, Ph.D||Sun Yat-sen University|