EUCTR2006-006088-22-DE
Active, not recruiting
Phase 1
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
Klinik für Chirurgie, Charité Campus Virchow-Klinikum0 sites180 target enrollmentFebruary 14, 2011
ConditionsPeritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junctionMedDRA version: 20.0Level: LLTClassification code 10042080Term: Stomach cancerSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10042081Term: Stomach cancer in situSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
- Sponsor
- Klinik für Chirurgie, Charité Campus Virchow-Klinikum
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) patients with gastric cancer incl. adenocarcinoma of the esophagogastreal junction and peritoneal carcinomatosis without any distant metastases with exception of Krukenberger tumosr
- •2\) peritoneal staging via laparoscopy and assessment of peritoneal carcinomatosis index (PCI) with the possibility of reduction (80% of the tumour) in line with zytoreductive surgery
- •3\) age \= 18 and \= 75 years
- •4\) Karnofsky Index \= 70%
- •5\) written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 180
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.) distant metastases except peritoneal carcinomatosis and Krukenberg tumors
- •2\.) other malignoma except curatively treated cervix carcinoma and basal cell carcinoma of the skin
- •3\.) previous chemotherapy or radiotherapx for peritoneal carcinomatosis
- •4\.) Inflammation in need of treatment
- •5\.) NYHA \> 2
- •6\.) Myocardial infarction
- •7\.) cardiac arrhythmia
- •8\.) high blood pressure, constant \> 180/100
- •9\.) cardiac function EF \< 55%
- •10\.) Limited heart function
Outcomes
Primary Outcomes
Not specified
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