Irinotecan Versus Only Best Supportive Care for Gastric Cancer
Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.
Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.
研究概览
详细说明
Metastatic gastric cancer, progressive disease after one palliative chemotherapy
Arm A:
Irinotecan 250/350 mg/m2 q3w
- Cycle:250mg/m2/ 30min
- Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care
研究类型
注册
阶段
- 第三阶段
联系人和位置
学习地点
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Berlin、德国
- Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
- Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
- Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
- Age 18 and 75 years
- Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal limit), ALT und AST < 3x upper normal limit
- Sufficient renal function, defined as serum creatinine < 1,25 x upper normal limit or creatinine clearance >60ml/min calculated according to Crockroft-Gault
- Contraction for patient with reproductive potential
- Karnofsky-Index >60%
- Measurable or evaluable tumor manifestation
Exclusion Criteria:
- Tumor progression later than 6 months after termination of first-line chemotherapy
- KI 50% or less
- Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
- Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
- Uncontrolled infection
- CNS metastases
- Other severe medical illness
- Prior major surgery less than 2 weeks ago
- Parallel treatment with another experimental therapy
- Parallel treatment with another therapy aiming at tumor reduction
- Chronic diarrhea, subileus
- Chronic inflammatory bowel disease or intestinal obstruction
- Pretreatment with irinotecan
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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中位生存期
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次要结果测量
结果测量 |
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quality of life, response rates, time to tumor progression, toxicity
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合作者和调查者
调查人员
- 首席研究员:P Reichardt MD PhD、Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin
- 首席研究员:PC Thuss-Patience MD PhD、Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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