NCT05741008已完成不适用
Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma
First Affiliated Hospital of Kunming Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1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
- 20
- 试验地点
- 1
- 主要终点
- incidence of acute mucosal ulcers with a toxicity grade 3 or above
研究概览
简要总结
To determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III).
- •The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage).
- •Patients who have not received radiation therapy before.
- •After induction chemotherapy, CR or PR were evaluated by radiography.
- •Age 18-65 years old.
- •ECOG score of 0-
- •Good organ function
- •The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs.
排除标准
- •Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded.
- •Patients with relapsed and distant metastases.
- •The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain).
- •Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx.
- •Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3).
- •Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment.
- •Those who have participated in clinical trials of other drugs within 3 months before treatment.
- •Pregnant or lactating women.
- •Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
结局指标
主要结局
incidence of acute mucosal ulcers with a toxicity grade 3 or above
时间窗: up to 6 months
incidence of acute mucosal ulcers (including those in the oral cavity and pharyngeal wall mucosa) with a toxicity grade 3 or above within 6 months after radiotherapy (that is, between the initiation of radiotherapy to 3 months postradiotherapy) among patients with no recurrence in the reduced-target area
次要结局
- Distant metastasis-free survival(up to 1 years)
- Overall survival(up to 1 years)
- Progress Free Survival(up to 1 years)
- Acute radiation toxicity(up to 3 months)
- locoregional recurrence-free survival(up to 1 year)
研究者
Zhiqiang, Wang
MD,Phd
First Affiliated Hospital of Kunming Medical University
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving ImmunotherapyNSCLCBreast CarcinomaBrain Metastases, AdultSmall-cell Lung CancerMelanomaNon-small Cell Lung CancerSCLCRenal Cell CarcinomaNCT05703269Wake Forest University Health Sciences58
招募中
2 期
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat CancerHPVThroat CancerOropharyngeal CarcinomaHuman Papilloma VirusOropharyngeal CancerNCT05491512Memorial Sloan Kettering Cancer Center121
已完成
不适用
Local Control With Reduced-dose Radiotherapy for High-Risk NeuroblastomaNeuroblastomaNCT02245997Memorial Sloan Kettering Cancer Center78
招募中
不适用
Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic CancerPancreatic CancerNCT02416609Azienda Ospedaliero-Universitaria di Modena44
已完成
不适用
Reduced Radiation in Patients With Diffuse Large B-cell LymphomaDiffuse Large B-cell LymphomaNCT01186978Duke University63