MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

Study Overview
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Brief Summary
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This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

Detailed Description
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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.

Official Title
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A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

Conditions
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Mediastinal Tumor

Intervention / Treatment
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* Combination Product: Unity-based MR-Linac guided Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years Histologically or cytologically confirmed mediastinal cancer Patients with inoperable mediastinal lesions Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN Informed-consent Exclusion Criteria: Patients with contraindications for MRI Previous radiotherapy or excision for mediastinal tumor The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava) A cavity over 2cm in diameter of primary tumor or metastasis Bleeding tendency or coagulation disorder Hemoptysis (1/2 teaspoon blood/day) happened within 1 month The use of full-dose anticoagulation within the past 1 month Severe vascular disease occurred within 6 months Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg) Major surgery within 28 days or minor surgery or needle biopsy within 48 hours Urine protein 3-4+, or 24h urine protein quantitative >1g Severe uncontrolled disease Uncontrollable seizure or psychotic patients without self-control ability Women in pregnancy, lactation period Other not suitable conditions determined by the investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-Linac Guided Adaptive Radiotherapy<br>Patients will receive Adaptive Radiotherapy on the MR-Linac treatment machine. | Combination Product: Unity-based MR-Linac guided Radiotherapy<br>* The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local-recurrence free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 2 months | 
| Progression-free survival |  | 2 years | 
| Overall survival |  | 2 years | 
| Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0 |  | 2 months | 
| Dose coverage to targets and normal organs |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MR-Linac, Mediastinal Tumor, Radiotherapy