NCT02289378Unknown2 期
Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
详细描述
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
- •Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
- •At least 3 weeks since last major surgery
- •At least 12 months since last adjuvant chemotherapy
- •At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
- •Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
- •Patients with reproductive potential must use effective BC
- •Required Screening Laboratory Criteria:
- •Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min
- •A probable life expectancy of at least 6 months
排除标准
- •Brain metastases
- •Female of childbearing potential, pregnancy test is positive
- •Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
- •Active infection
- •Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
- •Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
- •History of grade 3 or 4 toxicity to fluoropyrimidines
研究组 & 干预措施
Docetaxel, Oxaliplatin and 5-Fu
Experimental
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
干预措施: Docetaxel, Oxaliplatin and 5-Fu (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
次要结局
- Response rate(2 years)
研究者
Lan Ping
Professor
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric CancerGastric AdenocarcinomaNCT01567618Sixth Affiliated Hospital, Sun Yat-sen University39
已完成
2 期
Docetaxel and Oxaliplatin in Gastric CancerStomach NeoplasmsNCT00382720Sanofi275
Unknown
2 期
Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGCStomach NeoplasmStage IVRecurrentNCT00510107Gachon University Gil Medical Center90
已完成
2 期
Docetaxel+Oxali+/-Cetux Met Gastric/GEJGastric Cancer Adenocarcinoma MetastaticNCT00517829US Oncology Research150
进行中（未招募）
不适用
Phase II study: Treatment with the drug docetaxel and oxaliplatin for patients who have a confirmed metastatic or locally advanced cancer of the pancreas and in whom initial therapy has failed.EUCTR2005-004236-40-DEniversitätsklinikum Ulm44