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临床试验/NCT03047265
NCT03047265进行中(未招募)2 期

Phase II Randomized Trial Comparing Paclitaxel Combined With DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2017年2月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
164
试验地点
1
主要终点
3-year progress free survival(PFS)

研究概览

简要总结

This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

详细描述

Nasopharyngeal carcinoma is one of the most common malignancies in South China. Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Concurrent chemoradiation has become a standard treatment for locally advanced stage III-IVb nasopharyngeal carcinoma. However, The recommended single-agent DDP concurrent chemotherapy regimen for high-risk patients (IVa-IVb period) to improve the efficacy was not significant. Paclitaxel combined with platinum in the same period of chemotherapy regimen has been widely used in head and neck cancer, cervical cancer, esophageal squamous cell carcinoma and lung cancer and other tumors, a number of studies have shown that it has good tolerance and efficacy. And a number of previous studies have shown that paclitaxel combined with platinum chemotherapy in the same period of head and neck cancer or nasopharyngeal cancer in multiple phase II clinical trials to achieve encouraging results. Based on the above background and basis, for the high risk (IVa-IVb) nasopharyngeal carcinoma treatment, the applicant intends to carry out the first IMRT + paclitaxel + DDP concurrent chemotherapy compared with DDP single drug concurrent chemotherapy regimen Pharyngeal cancer in a prospective randomized controlled phase Ⅱ clinical trial for paclitaxel + DDP dual-chemotherapy regimen for the treatment of high-risk nasopharyngeal carcinoma to provide evidence-based basis. (IVa-IVb) nasopharyngeal carcinoma (NPC), and to provide a high-level evidence-based evidence-based approach to the treatment of nasopharyngeal carcinoma at high risk (stage IVa-IVb). The results of this study will be used in international guidelines to optimize high- Treatment of cancer patients.

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
Double (Participant, Care Provider)

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

入选标准

  • Patients with newly histologically confirmed non-keratinizing carcinoma.
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
  • Original clinical staged as IVa-IVb(according to the 7th AJCC edition).
  • Male and no pregnant female
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-
  • WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  • With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)
  • Written informed consent.

排除标准

  • Patients have evidence of relapse or distant metastasis Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Receiving radiotherapy or chemotherapy previously
  • The presence of uncontrolled life-threatening illness
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent systemic steroid therapy
  • HIV positive
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

研究组 & 干预措施

Paclitaxel

Experimental

Paclitaxel plus Cisplatin combine with IMRT

干预措施: Paclitaxel (Drug)

Cisplatin

Active Comparator

Cisplatin combine with IMRT

干预措施: Cisplatin (Drug)

结局指标

主要结局

3-year progress free survival(PFS)

时间窗: 3 years

PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups

次要结局

  • overall survival(OS)(2 years ,3 years and 5 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Guo

PROFESSOR

Sun Yat-sen University

研究点 (1)

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