Peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction MedDRA version: 20.0 Level: LLT Classification code 10042080 Term: Stomach cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10042081 Term: Stomach cancer in situ System Organ Class: 100000004864
Conditions
Interventions
Product Name: Epirubicin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: EPIRUBICIN
CAS Number: 56420452
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for in
Sponsors
Klinik für Chirurgie, Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
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 11.) Insufficient renal function 12.) Insufficient liver function 13.) vaccinations during the last 6 weeks 14.) Active hepatitis B/C 15.) Pregnancy / lactation 16.) No effective contraception 17.) Missing of capacity to contract 18.) contraindication to the drugs which are used in the trial 19.) Participation in another investigational drug trial 20.) Persons institutionalised due to regulatory actions ore by court order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) (extension of survival starting at randomisation) by combination of pre-and postoperative chemotherapy + cytoreductive surgery and HIPEC compared to pre-and postoperative chemotherapy + cytoreductive surgery without HIPEC ;Secondary Objective: Secondary objectives are the evaluation of: 1. safety problems of HIPEC lasting for a short time (30-days complication rate) 2. time to verifiable progress of tumour 3. time to appearance of elsewhere localised metastases 4. quality of life 5. frequency of toxicity and adverse events 6. frequency of required surgical and therapeutic intervention 7. duration of hospitalisation ;Primary end point(s): Time from randomisation to death;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. for a short time safety problems of HIPEC ( 30-days complication rate) 2. Time to verifiable progress of tumour 3. Time of appearance of elsewhere localised metastases 4. Quality of life 5. frequency of toxicity and adverse events 6. frequency of required surgical and therapeutic intervention 7. Duration of hospital stay ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Germany
Contacts
Public ContactBeate Rau
Chirurgie, Charité Campus Virchow-Klinikum
Outcome results
None listed