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临床试验/NCT06531681
NCT06531681招募中不适用

The Second Affiliated Hospital of Hainan Medical University

The Second Affiliated Hospital of Hainan Medical University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
overall response rate

研究概览

简要总结

Aim to observe the application of MR-Linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,Characteristics of dosimetric parameters etc.

详细描述

Primary endpoint:

· Overall response rate (ORR) : It refers to the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time requirement, which is a Complete Response (CR) and a partial response (PR). Partial Response) sum of the proportions.

Secondary points:

  • Progression-free Survival (PFS) : the time from the start of treatment until objective tumor Progression or all-cause death of the patient.
  • Disease Control Rate (DCR) : The percentage of patients whose cancer shrinks or remains stable over time.
  • Overall Survival (OS) : the time from the start of treatment to all-cause death.
  • Incidence of adverse reactions: toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE).
  • Quality of life: The EORTC Quality of Life measure -QLQ-C30-(V3.0) was used, and the higher the score, the higher the quality of life.
  • Dosimetric parameters: include gross target volume(GTV), clinical target volume(CTV),internal target volume(ITV),planning target volume(PTV),γ-passing rate,and limited dose of organs at risk (including average dose, maximum dose, etc.)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Patients are undergoing or have undergone imaging or treatment at the MR linac;
  • Age 18-75 years, male or female;
  • ECOG score 0-2, life expectancy > 6 months;
  • Patients provide written informed consent.

排除标准

  • Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;
  • The presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy;
  • Acute inflammatory disease requiring systemic therapy;
  • The presence of active infectious disease;
  • Pregnant women, nursing mothers, and patients planning to have children during the study period.

结局指标

主要结局

overall response rate

时间窗: 3months, 6months,12months,24months,36months,60months

The proportion of patients whose tumor volume reduction reached the predetermined value and maintained the minimum time limit requirement was the sum of CR (Complete Response) and PR (Partial Response) proportions.

次要结局

  • Progression-Free Survival(3months, 6months,12months,24months,36months,60months)
  • Incidence of adverse reactions(3months, 6months,12months,24months)
  • Overall survival(3months, 6months,12months,24months,36months,60months)
  • Dosimetric parameters:dose of target volume(TV)(During Radiotherapy)
  • Disease Control Rate(3months, 6months,12months,24months,36months,60months)
  • Dosimetric parameters:γ passing rate(During Radiotherapy)
  • Dosimetric parameters:OAR(During Radiotherapy)
  • Patient reported Health related quality of life (HRQoL)(3months,6months,12months,24months)

研究者

发起方
The Second Affiliated Hospital of Hainan Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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