Parenteral Nutrition during neoadjuvant chemotherapy for patients with advanced cancer of the GE-junction/esophagus/stomach/pancreas or rectum for reduction of postoperative morbiditiy - PERCOG

Technische Universitaet Muenchen Fakultaet fuer Medizin0 个研究点目标入组 150 人开始时间: 2017年3月20日最近更新: 2021年11月15日

适应症

试验速览

暂无简介。

•1. Histologically proven locally advanced carcinoma of
•GE- junction or
•Esophagus or
•Pancreas or
•Requiring neoadjuvant chemotherapy or radio-(chemo-)therapy ahead of surgery
•2. Nutritional Risk Score (NRS) =3
•3. Age>18 years
•4. ECOG grade 0-2
•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
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Non-resectable carcinoma of the GE-junction, esophagus, stomach, pancreas or rectum
•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.

发起方

Technische Universitaet Muenchen Fakultaet fuer Medizin