Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Recurrence free survival (RFS)
研究概览
简要总结
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
详细描述
This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 (according to World Health Organization (WHO) histologically type).
- •Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).
- •No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) >
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- •Normal liver 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.
- •Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.
- •unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Pregnancy or lactation. 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. 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.
- •satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
研究组 & 干预措施
Endostatin and Capecitabine
Patients received radiotherapy Combined With Endostatin and Capecitabine
干预措施: Endostatin and Capecitabine (Drug)
结局指标
主要结局
Recurrence free survival (RFS)
时间窗: 3 years
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
次要结局
- overall survival (OS)(5 years)
- distant metastasis-free survival (DMFS)(3 years)
- Local-regional free survival (LRFS)(3 years)
- adverse events (AEs) and severe adverse events (SAE)(5 years)
- quality of life (QoL)(3 years)
研究者
Jin Ting
MD
Zhejiang Cancer Hospital