A Multicenter, Randomized Controlled Phase III Clinical Trial of GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Progress-free survival(PFS)
研究概览
简要总结
Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
- •Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
- •III, IVa patients (AJCC version 8 staging).
- •Male or non-pregnant women.
- •Age ≥ 18 and < 70 years old.
- •Functional status: Karnofsky scale (KPS) >
- •White blood cells (WBC) ≥ 4 ×
- •/L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)
- •Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
- •Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.
- •The patient has signed an informed consent form.
排除标准
- •The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- •Age ≥ 70 years old or < 18 years old.
- •Treatment is palliative.
- •Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
- •Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
- •Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
- •Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
- •With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN),And mental illness.
研究组 & 干预措施
GP+CCRT
GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: GP+CCRT (Drug)
TPF+CCRT
TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: TPF+CCRT (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
- Overall survival(OS)(3 years)
- Locoregional failure-free survival(LRFS)(3 years)
- Distant metastasis-free survival(DMFS)(3 years)
- Overall response rate(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