NCT03791944已完成不适用
3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study
Xinqiao Hospital of Chongqing1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.
详细描述
The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoint was the local control rate and the incidence of treatment-related side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consolidate other serious diseases that affect quality of life or treatment;
- •Reluctant to actively cooperate with the investigator;
- •Mergers with distant transfers;
- •Patients who have undergone head and neck surgery and radiotherapy;
- •Subjects who are affected by the disease who sign a written informed consent or follow the study procedure; or who are unwilling or unable to comply with the research requirements.
- •Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- •Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
- •Pregnant or lactating women;
- •The investigator judges other conditions that may affect the clinical study and the outcome of the study.
排除标准
- •Those who did not follow the protocol.
- •The subject is aggravated or has a serious adverse reaction.
- •The subject himself requested to withdraw from the trial.
- •The patient is lost to follow-up or died.
- •The researcher believes that there is reason to withdraw
结局指标
主要结局
Objective response rate
时间窗: 3 months follow-up after treatment
Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
次要结局
- Local control rate(3 months follow-up after treatment)
- incidence of treatment-related side effects(3 months follow-up after treatment)
研究者
Jianguo Sun
Deputy director
Xinqiao Hospital of Chongqing
研究点 (1)
Loading locations...
相似试验
已完成
不适用
3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal CarcinomaRadiotherapyNasopharyngeal CarcinomaNCT03810274Xinqiao Hospital of Chongqing300
招募中
2 期
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPCAdvanced Nasopharyngeal CarcinomaNCT05652192Zhejiang Cancer Hospital37
Unknown
2 期
Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma Receiving IMRTNasopharyngeal NeoplasmsRadiodermatitisNCT02729324Yun-fei Xia136
招募中
3 期
Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment ResponseNasopharyngeal CarcinomaNCT06239727Sun Yat-sen University593
已完成
不适用
Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma.Nasopharyngeal CarcinomaNCT00188253University Health Network, Toronto30