TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 8
- 主要终点
- Progression-free survival
研究概览
简要总结
The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.
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
- •Age between 18 and 65 years;
- •Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma (WHO type II or III);
- •Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition);
- •Easte Cooperative Oncology Group performance status of 0 or 1;
- •Adequate bone marrow: leucocyte count ≥ 4×109/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×109/L;
- •Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN;
- •Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN;
- •Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment;
- •Patients must be appraised of the investigational nature of the study and provide written informed consent.
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma;
- •Treatment with palliative intent;
- •Prior malignancy (except for adequately treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin);
- •History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume);
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
- •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;
- •Prior allergic reaction to the study drug(s) involved in this protocol.
研究组 & 干预措施
TPC induction chemotherapy + CCRT
TPC induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)
干预措施: TPC induction chemotherapy (Drug)
GP induction chemotherapy + CCRT
GP induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)
干预措施: GP induction chemotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
次要结局
- Overall survival(2 years)
- Short-term response rate(32 weeks)
- Locoregional progression(2 years)
- Distant progression(2 years)
- Incidence of acute and late toxicity(2 years)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University