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
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
- 否
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
FLOT
干预措施: Docetaxel (Drug)
1
FLOT
干预措施: 5-Fluorouracil (Drug)
1
FLOT
干预措施: Oxaliplatin (Drug)
1
FLOT
干预措施: folinic acid (Drug)
2
FLO
干预措施: 5-Fluorouracil (Drug)
2
FLO
干预措施: Oxaliplatin (Drug)
2
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