Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC： a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of this study is to study the efficacy and safety of nedaplatin versus cisplatin, and capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF) plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced nasopharyngeal carcinoma (NPC).
详细描述
In this study, patients with non-keratinizing NPC and staged III-IVA (except T3-4N0) are randomly assigned to one of the four groups: Group A: TPF+P-RT; Group B: TNF+N-RT; Group C: TPX+P-RT; Group D: TNX+N-RT. In induction chemotherapy, patients will receive docetaxel(60 mg/m2 on day 1), cisplatin or nedaplatin (60 mg/m2 on day 1) and fluorouracil (600 mg/m2 on Days 1 to 5) or capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radical radiotherapy. Concurrent cisplatin or nedaplatin (100mg/m2 on day 1) was given every three weeks for two cycles during radiotherapy. Patients are stratified according to the treatment centers and stage. The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-60
- •Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type)
- •Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
- •Tumor staged as American Joint Committee on Cance (AJCC) III-IVA (except T3-4N0)
- •Adequate marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L.
- •Normal liver and renal function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN; creatinine clearance ≥ 60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
- •Patients who could not tolerate or allergic to capecitabine.
- •Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.
研究组 & 干预措施
A (TPF+P-RT)
Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin
干预措施: docetaxel, cisplatin, and fluorouracil (Drug)
A (TPF+P-RT)
Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin
干预措施: cisplatin (Drug)
B (TNF+N-RT)
Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin
干预措施: nedaplatin (Drug)
B (TNF+N-RT)
Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin
干预措施: docetaxel, nedaplatin, and fluorouracil (Drug)
C (TPX+P-RT)
Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin
干预措施: cisplatin (Drug)
C (TPX+P-RT)
Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin
干预措施: docetaxel, cisplatin, and capecitabine (Drug)
D (TNX+N-RT)
Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin
干预措施: docetaxel, nedaplatin, and capecitabine (Drug)
D (TNX+N-RT)
Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin
干预措施: nedaplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
Progression-free survival is calculated from the date of randomisation to the date of disease progression or death from any cause, whichever is first.
次要结局
- Overall survival(3 years)
- Distant failure-free survival(3 years)
- Locoregional failure-free survival(3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (acute toxicity) and RTOG/EORTC (late toxicity)(Up to 3 years)
- Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30(Up to 16 weeks)
研究者
Jun Ma, MD
Prof
Sun Yat-sen University