Prospective multicenter phase III clinical trial using cytoreductive surgery with hyperthermic intraoperative chemotherapy (HIPEC)after preoperative chemotherapy in patients with peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction - Gastripec I

Charité Campus Charité Mitte0 sites105 target enrollmentNovember 23, 2011

Overview

No summary available.

Registry

who.int

Start Date

November 23, 2011

End Date

June 9, 2020

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Charité Campus Charité Mitte

•1\. Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG
•No evidence of other distant metastases than peritoneal carcinomatosis with exception of Krukenberger tumors
•2\. Peritoneal Staging with laparoscopy (or explorative laparotomy) and estimation of Peritoneal Cancer Index (PCI) with the possibility of 80% tumorreduction at cytoreductive surgery
•3\. \= 18 and \= 75 years
•4\. Karnofsky Index 70% or better
•5\.Written informed consent is obtained prior to commencement of trial treatment.

•1\. Other than peritoneal metastasis of the gastric cancer incl. AEG and Krukenberg
•2\.Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
•3\.Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
•4\.Active systemic infections
•5\.Patients with known interstitial lung disease with New York Heart Association classification \> 2
•6\.Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
•7\. cardiac arrhythmia
•8\.Uncontrolled hypertension (diastolic blood pressure constantly \>100 mm Hg, systolic blood pressure constantly \> 180 mm Hg).
•9\.Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 GPT/L or neutrophil granulocyt count less than \<1\.5 GPT/L
•10\. cardiac function EF \< 55%