Mediastinal Tumor
Conditions
Keywords
Mediastinal Tumor, MR-Linac, Radiotherapy
Brief summary
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.
Detailed description
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.
Interventions
COMBINATION_PRODUCTUnity-based MR-Linac guided Radiotherapy
The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local-recurrence free survival | 2 years |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactDaquan Wang, M.D
Backup ContactBo Qiu, M.D
Outcome results
None listed