The Effect of Celecoxib on Concurrent Chemoradiation With Weekly Nedaplatin in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of patients with different tumor response and short term toxicity will be recorded
研究概览
简要总结
The purpose of this study is to determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.
详细描述
- Study Patients:
Patients are all recruited from the Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. All the patients provide written informed consent before enrollment. All eligible patients received a pretreatment evaluation including complete history and physical examination, endoscopic biopsy, routine laboratory tests for hematologic, renal and hepatic function as well as a dental and nutritional evaluation prior to treatment. Radiological investigations consisted of computed tomography (CT) scan or magnetic MRI of the nasopharynx, chest radiography, ultrasound of the upper abdomen and bone scintigraphy. Pathologic confirmation of nasopharyngeal cancer (NPC) was performed and re-classified according to the world health organization (WHO) subtypes. 2. Study design:
A total of 120 NPC patients are randomly and equally divided into two groups: Nedaplatin alone concurrent radiotherapy, Celecoxib plus nedaplatin concurrent radiotherapy. The tumor response will be evaluated by magnetic resonance imaging (MRI) after 4 weeks. The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. The show term or long term toxicity will be evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0. All the NPC patients are requested to be followed up with an expected average of every 3 months after the therapy.The other clinical outcomes including the first evidence of cancer progression or death from any cause, the occurrence of distant metastasis, and the relapse of a local or nodal tumor will be evaluated as well. The follow-up will be up to 2018. 3. Statistical Analysis:
Statistical Package for the Social Sciences (SPSS 13.0) is used to analyze the effect of celecoxib on the nedaplatin concurrent radiotherapy. Cox's regression model and Kaplan-Meier method is used to conduct survival analysis. Clinical outcomes including the tumor responses, 1-year/3-year/5-year overall survival (OS), progression free survival (PFS), distant metastasis failure-free survival (DMFS) and locoregional failure-free survival (LFFS) will be analyzed. The multivariate Cox's regression model is used to adjust the confounders, including age and body mass index. P value less than 0.05 will be considered to be statistically significant.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
concurrent_radiochemotherapy
Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
干预措施: Nedaplatin (Drug)
concurrent_radiochemotherapy
Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
干预措施: Concurrent Radiotherapy (Radiation)
celecoxib_radiochemotherapy
Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
干预措施: Celecoxib (Drug)
celecoxib_radiochemotherapy
Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
干预措施: Nedaplatin (Drug)
celecoxib_radiochemotherapy
Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
干预措施: Concurrent Radiotherapy (Radiation)
结局指标
主要结局
Number of patients with different tumor response and short term toxicity will be recorded
时间窗: Patients are asked to be followed within an expected average of 4 weeks after therapy
The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) were evaluated by MRI, according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0; Short term toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.
次要结局
- Age will be recorded when the therapy starts(Patients are asked to provide the birthday before the start of therapy)
- The date when each patient is dead will be recorded.(Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented death from any cause, assessed up to 36 months.)
- The date when each patient presents the occurrence of distant metastasis will be recorded.(Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented occurrence of distant metastasis, assessed up to 36 months)
- The date when each patient presents the relapse of a local or nodal tumor will be recorded.(Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented relapse of a local or nodal tumor, whichever came first, assessed up to 36 months.)
- Height in meters and weight in kilograms will be recorded when therapy starts(Patients are asked to be measured the height and weight before the start of therapy)
- The date when each patient shows the first evidence of cancer progression or death from any cause will be recorded.(Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever comes first, up to 36 months)
- Long term toxicity will be recorded as the Number of Participants with Treatment-Related Adverse Events(Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the documented date of the Treatment-Related Adverse Events, whichever comes first, assessed up to 36 months.)
研究者
Changjie Huang
head of the medical department
Nanning Second People's Hospital