跳至主要内容
临床试验/JPRN-jRCTs041180110
JPRN-jRCTs041180110已完成3 期

Carboplatin plus nab-Paclitaxel versus docetaxel for elderly squamous non-small cell lung cancer - CAPITAL study

Gemma Akihiko0 个研究点目标入组 196 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
196

研究概览

简要总结

The combination of carboplatin plus nab-paclitaxel in advanced squamous cell lung cancer in elderly patients significantly prolongs overall survival and is a more useful treatment than docetaxel.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 70age old 至 ot applicable(—)
性别
All

入选标准

  • 1) Histologically or cytologically confirmed advanced squamous non-small-cell lung cancer
  • 2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
  • 3) Regardless of the presence of measurable lesions
  • 4) 70 years of age or older
  • 5) Performance status of 0 or 1
  • 6) Adequate organ function
  • 7) life expectancy 12 weeks or more at day1
  • 8) Written informed consent

排除标准

  • 1) symptomatic central nervous system metastases
  • 2) A past hypersensitive for polysorbate or albumin
  • 3) peripheral neuropathy CTCAE Grade 2 or more
  • 4) uncontrolled pericardial or pleural effusion or ascites
  • 5) prior palliative radiotherapy for metastatic lesion within 14 days before registration
  • 6) Synchronous or metachronous active double malignancies
  • 7) Infectious disease requiring systemic treatment or severe complications
  • 8) do not consent to contraception
  • 9) Positive for HBs antigen
  • 10) positive for HBs antibody or HBc antibody, and positive for HBV-DNA
  • 11) patients who have been judged by the investigator to be inappropriate in this clinical trial for other reasons

研究者

发起方
Gemma Akihiko

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