A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.
详细描述
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition）
- •No evidence of distant metastasis (M0)
- •Male and no pregnant female
- •Age between 18-65
- •WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3
- •With normal liver function test (ALT、AST ≤ 2.5×ULN)
- •With normal renal function test (Creatinine ≤ 1.5×ULN)
- •Satisfactory performance status: Karnofsky scale (KPS)> 70
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Patients have evidence of relapse or distant metastasis
- •The presence of uncontrolled life-threatening illness
- •Receiving other ways of anti-cancer therapy
- •Receiving radiotherapy or chemotherapy
- •Pregnancy or lactation
研究组 & 干预措施
Nedaplatin
Nedplatin combine with IMRT
干预措施: Nedaplatin (Drug)
Cisplatin
Cisplatin combine with IMRT
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 2 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
次要结局
- Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.(4 weeks)
- Complete Response (CR)(after the completion of the chemoradiotherapy treatment (up to 9 weeks))
- Overall Survival(OS)(2 years)
- Locoregional Relapse-Free Survival(LRRFS)(2 years)
- Distant Metastasis-Free Survival (DMFS)(2 years)
- Anti-neoplasms sensitization effects of chemotherapy to radiotherapy(radiotherapy in 20Gy、40Gy、70Gy)
- Cost-effectiveness analysis(completion of chemoradiotherapy)
- Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome(before chemoradiotherapy and after chemoradiotherapy)
研究者
Hai-Qiang Mai,MD,PhD
Deputy Director of the Department of Nasopharyngeal Carcinoma
Sun Yat-sen University