EUCTR2009-014895-23-DE进行中（未招募）1 期
Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial - FLOTIRI
niversitätsklinikum Erlangen0 个研究点目标入组 50 人开始时间: 2013年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven advanced adenocarcinoma of the stomach or the gastro-oesophageal junction with distant metastases including lymph node metastasis, e.g. supraclavicular or para-aortal (M1 [HEP, PUL, LYM] (UICC stage IV)
- •Age: = 18 und = 75 years
- •Life expectancy: minimum 3 months
- •ECOG index 0-2
- •Sufficient bone marrow function defined as leucozytes ? 3.500/µl, thrombocytes ? 100.000/µl
- •Sufficient renal function defined as serum creatinine ? 2,0 mg/dl or creatinin clearance > 30 ml/min.
- •Sufficient hepatic function defined as serum bilirubine ? 2,0 mg/dl, exception: orbus Gilbert-Meulengracht
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Hypersensibility to 5-FU, sodium folinate, irinotecan, docetaxel oder oxaliplatin
- •Previous systemic chemotherapy
- •Severe concomitant diseases which preclude therapy
- •Bone marrow suppression
- •Chronic diarrhoea (> NCI – CTC - grade 1)
- •Chronic inflammatory intestinal diseases or subtotal intestinal obstruction
- •Concomitant therapy with other anticancer drugs
- •Treatment with allopurinol and trimethroprim
- •Pregnancy and lactation
- •No adequate contrazeption for pre-menopausal females
- •Participation in clinical trials with non-approved drugs
研究者
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