Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.
详细描述
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al. demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did not increase the treatment induced toxicities when compared with RT alone. Therefore, we initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for locally advanced NPC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
- •Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
- •ECOG performance status of 0-1
- •Life expectancy of more than 6 months
- •Signed written informed consent
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 109/l
- •Platelets count >= 100 * 109/l
- •Hemoglobin >= 10 g/dl
- •AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- •Total bilirubin <= 1.5 times institutional ULN
- •Creatinine clearance >= 50 ml/min
- •Serum creatine <= 1 times ULN
排除标准
- •Evidence of distant metastasis
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
研究组 & 干预措施
cisplatin-radiotherapy (CRT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
干预措施: Docetaxel (Drug)
cisplatin-radiotherapy (CRT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
干预措施: Intensity-modulated radiotherapy (Radiation)
cisplatin-radiotherapy (CRT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
干预措施: Cisplatin (Drug)
cetuximab-radiotherapy (ERT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
干预措施: Cetuximab (Drug)
cetuximab-radiotherapy (ERT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
干预措施: Cisplatin (Drug)
cetuximab-radiotherapy (ERT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
干预措施: Docetaxel (Drug)
cetuximab-radiotherapy (ERT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
干预措施: Intensity-modulated radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: up to 3 years
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.
次要结局
- Overall survival(up to 3 years)
- Locoregional recurrence-free survival(up to 3 years)
- Distant metastasis-free survival(up to 3 years)
- Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0(1, 2, 3 weeks post-dose)
- Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0(Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy)
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy(At 3 months after completion of radiotherapy)
研究者
Guo-Pei Zhu
M.D., Associated Professor
Fudan University