This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors. Patients will receive radiotherapy on the MR-Linac treatment machine. The primary end point is 2-year local-recurrence free survival. The secondary end points are objective response rate, 2-y PFS, 2-y OS, safety of treatment, dose coverage of targets and dose to normal organs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.
Hui Liu
Guangzhou, Guangdong, China
RECRUITINGLocal-recurrence free survival
Time frame: 2 years
Objective response rate
Time frame: 2 months
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0
Time frame: 2 months
Dose coverage to targets and normal organs
Time frame: 2 months
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