DRKS00009451进行中（未招募）3 期
Parenteral nutrition during neoadjuvant chemotherapy for patients with non-metastatic gastric or gastroesophageal cancer to reduce postoperative morbidity - PERCOG
Technische Universität München, Fakultät für Medizin,0 个研究点目标入组 15 人开始时间: 2017年7月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
SPN cannot be recommended for reduction of postoperative complications after neoadjuvant multimodal therapy for gastro-esophageal, pancreatic or rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.) Histologically proven resectable adenocarcinoma of the stomach or gastroesophageal junction (AEG I-III) staged cT2/cN+ to cT4/cNany without distant metastasis.
- •2.) Age >= 18 years
- •3.) ECOG stage 0-2
- •4.) Nutritional Risk Score (NRS) =3
- •5.) Negative proof of pregnancy for potentially childbearing women.
- •6.) Sufficient bone-marrow, liver- and kidney-function according to the attending oncologist´s expert opinion.
排除标准
- •1.) Non-resectable adenocarcinoma of the stomach or gastroesophageal junction.
- •2.) Participation in a different randomized controlled trial potentially interfering with the primary endpoint.
- •3.) Pregnancy or breast feeding.
- •4.) Impairing cardiac disease such as unstabel angina pectoris, unstable coronary heart disease, cardiac failure (NYHA IV), malignant hypertension) or pulmonary disease (COPD stage GOLD IV), representeing a contraindication to neoadjuvant chemotherapy or surgical resection.
- •5.) Insufficient patient compliance.
研究者
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