NCT03723343Unknown不适用
Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma
Guiyang Medical University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2018年10月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Progress-free survival(PFS)
研究概览
简要总结
Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.
详细描述
- The main purpose: Whether the GP program can improve the efficiency of patients with nasopharyngeal carcinoma, especially overall survival (OS), in the TPF program. 2. Secondary purpose: To compare the progression-free survival (PFS) local failure-free survival (LR-FFS), the short-term remission rate of the tumor, the adverse chemotherapy response, and the treatment compliance Sex, as well as quality of life. 3. Significance of the research project Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Platinum-based chemotherapy is used in the treatment of distant metastasis and metastasis. It can effectively alleviate local symptoms and reduce local symptoms. The tumor volume thereby reduces the high dose area of the target area. Primary lesions and lymphatic drainage area radiotherapy can reduce tumor burden, relieve symptoms, and improve quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO).
- •The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I).
- •There is evidence of distant transfer (M1).
- •functional status: Karnofsky scale (KPS) > 70 (Appendix II).
- •normal bone marrow function: white blood cell count > 4 × 109 / L, hemoglobin > 90g / L and platelet count > 100 × 109 / L.
- •normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (alkaline phosphatase, ALP) < 2.5 x ULN and bilirubin < ULN.
- •normal renal function: creatinine clearance (creatinine clearance) > 60 ml / min.
- •The patient must be informed of the basic content of the study and sign an informed consent form.
排除标准
- •the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- •age > 65 years old or < 18 years old.
- •a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
- •Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
- •has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed
- •Except for the target area of treatment.
- •primary lesions and cervical metastases have received chemotherapy or surgery (except for diagnostic treatment).
- •accompanied by other serious diseases, may bring greater risk or affect the compliance of the test. For example: unstable heart disease, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose > 1.5 x ULN), and mental illness. -
研究组 & 干预措施
Experimental: GP+IMRT
Test group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone
干预措施: GP+IMRT (Drug)
Active Comparator: TPF+IMRT
Control group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1~d5, 5-fluorouracil 750 mg/m2/dd1~d5, 4/6 course) + IMRT radiotherapy alone
干预措施: TPF+IMRT (Drug)
结局指标
主要结局
Progress-free survival(PFS)
时间窗: 3 years
Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
次要结局
- Distant metastasis-free survival(DMFS)(3 years)
- Overall response rate(3 years)
- Locoregional failure-free survival(LRFS)(3 years)
- Overall survival(OS)(3 years)
- Incidence of acute and late toxicity(3 years)
研究者
Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Guiyang Medical University
研究点 (1)
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