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临床试验/NCT00737373
NCT00737373已完成2 期

A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile

Krankenhaus Nordwest1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
143
试验地点
1
主要终点
response (WHO criteria)

研究概览

简要总结

In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.

详细描述

Patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with:

  • Arm A: FLO
  • Arm B: FLOT

max. 12 cycles

Evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm)

primary endpoint:

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
  • no prior chemotherapy in metastatic state
  • adequate blood and biochemistry parameters

排除标准

  • hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
  • KHK, cardiomyopathy or cardiac insufficiency
  • malignancy <5 years ago
  • brain metastases
  • severe internal disease or inadequate blood and biochemistry parameters

研究组 & 干预措施

1

Experimental

FLOT

干预措施: Docetaxel (Drug)

1

Experimental

FLOT

干预措施: 5-Fluorouracil (Drug)

1

Experimental

FLOT

干预措施: Oxaliplatin (Drug)

1

Experimental

FLOT

干预措施: folinic acid (Drug)

2

Active Comparator

FLO

干预措施: 5-Fluorouracil (Drug)

2

Active Comparator

FLO

干预措施: Oxaliplatin (Drug)

2

Active Comparator

FLO

干预措施: folinic acid (Drug)

结局指标

主要结局

response (WHO criteria)

时间窗: staging every 8 weeks

次要结局

未报告次要终点

研究者

发起方
Krankenhaus Nordwest
申办方类型
Other
责任方
Sponsor

研究点 (1)

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