NCT05163509Unknown2 期
A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Local-recurrence free survival
研究概览
简要总结
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Local-recurrence free survival
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Objective response rate(2 months)
- Dose coverage to targets and normal organs(2 months)
- Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0(2 months)
- Progression-free survival(2 years)
研究者
Hui Liu
Professor
Sun Yat-sen University
研究点 (1)
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