Clinical trial NCT05163509: MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Official title: A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mediastinal Tumor
Keywords: Mediastinal Tumor
MR-Linac
Radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local-recurrence free survival
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 2 months
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0
timeFrame: 2 months
measure: Dose coverage to targets and normal organs
timeFrame: 2 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hui Liu
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu
role: PRINCIPAL_INVESTIGATOR
References:
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