A Phase 3, Open Label, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ulinastatin in the Reduction of Acute Oral Mucositis Caused by Concurrent Chemoradiotherapy(CCRT) for Patients With Localregionally Advanced Nasopharyngeal Carcinoma (NPC).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3)
研究概览
简要总结
This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.
详细描述
Radiation-induced acute oral mucositis (RTOM) in Nasopharyngeal Carcinoma (NPC) patients treat with concurrent chemoradiotherapy (CCRT) is common. Currently, there is no effective treatment for RTOM. Ulinastatin, is a kind of natural anti-inflammatory substance. And this substance is insufficient when the body's inflammatory response is strongly. There are a series of studies have confirmed the efficacy and safety of ulinastatin in the treatment of body's inflammatory response. From the observation of our previous clinical practice, we found that ulinastatin can relieve the severity of RTOM. The present study is undertaken to evaluate the efficacy of ulinastatin in the treatment of RTOM in localregionally advanced NPC patients treated with CCRT.
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
- 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
- •Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
- •Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
- •Karnofsky Performance Status Scale between 80-100
- •WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
- •ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- •Sign the informed consent.
排除标准
- •Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
- •Younger than 18 years old or older than 70 years old
- •Pregnancy or lactation
- •Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- •Have suffered from other tumor or now suffering from other tumor
- •Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
- •Refuse to give up smoking/drinking/betel chewing
- •suffering from other active infection diseases and in need of treatment.
研究组 & 干预措施
Concurrent chemoradiotherapy and ulinastatin
Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows:
- Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT;
- Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Concurrent chemoradiotherapy
Concurrent chemoradiotherapy (CCRT) alone:
Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Concurrent chemoradiotherapy and ulinastatin
Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows:
- Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT;
- Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.
干预措施: Cisplatin (Drug)
Concurrent chemoradiotherapy and ulinastatin
Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows:
- Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT;
- Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.
干预措施: Ulinastatin (Drug)
Concurrent chemoradiotherapy
Concurrent chemoradiotherapy (CCRT) alone:
Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3)
时间窗: Up to 19 weeks
The primary outcome measures planned in the protocol were the incidence of actue oral mucositis grade greater than or equal to 3 using the Common Terminology Criteria for Adverse Events of Version 4.03 (CTCAE 4.03) in the experimental group and control group. CTCAE 4.03 grade 3 = severe pain; interfering with oral; CTCAE 4.03 grade 4 = Life-threatening consequences; urgent intervention indicated; CTCAE 4.03 grade 5 = death. Mucositis will be assessed weely during concurrent chemoradiotherapy (CCRT) for 7 weeks, and assessed once at 1 month after CCRT and 3 months after CCRT, respectively. The whole observation time may up to 19 weeks.
次要结局
- Oral Assessment Guide (OAG) Score(Up to 19 weeks)
- Weeks to Onset of Severe Radiation-Induced Acute Oral Mucositis (Grade of CTCAE ≥ 3)(Up to Week 19)
- Oral Mucositis Scores by World Health Organization (WHO)(Up to 19 weeks)
- Rate of Participants With Unplanned Breaks in Radiotherapy(During the 7 weeks for concurrent chemoradiotherapy)
- Quality of Life with EORTC QLQ-C30(Up to 19 weeks)
- Karnofsky Performance Status Scale(Up to 19 weeks)
- Numeric Rating Scale for Pain(NRS scale)(Up to 19 weeks)
- 3 Months Overall Response Rate(Assessed at 3 months after concurrent chemoradiotherapy)
- The Adverse events Related to Ulinastatin(Up to 19 weeks)
研究者
Zhao Chong
Clinical Professor
Sun Yat-sen University