A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.
详细描述
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma. Patients will receive hypofractionated radiotherapy with concurrent chemotherapy.
Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.
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
- •Histologically confirmed type AB or B1-3 thymoma.
- •Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).
- •Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.
- •Between the ages of 18 and 70 years, regardless of sex.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •No prior chest radiation.
- •Adequate organ Functions.
- •Written informed consent obtained.
排除标准
- •Contraindications to Methylprednisolone.
- •History of or Concurrent Malignancy.
- •Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.
- •Pregnant or Lactating Women.
- •Bleeding Disorders.
- •Recent Participation in Other Clinical Trials.
- •Drug Abuse or Severe Alcoholism.
- •Uncontrolled Seizures or Mental Disorders.
- •Severe Allergies or Specific Sensitivities.
研究组 & 干预措施
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
干预措施: Radiotherapy (Radiation)
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
干预措施: Concurrent chemotherapy (Drug)
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Objective response rate
时间窗: 1-2 months after chemoradiotherapy
The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy
次要结局
- Progression-free survival(2-year)
- Overall survival(2-year)
- Toxicities using the CTCAE 5.0(1 year after treatment)
- Quality of life scores(1 year after treatment)
研究者
Hui Liu
Professor
Sun Yat-sen University