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 junctio

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 105

Inclusion Criteria

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.

Exclusion Criteria

1. Other than peritoneal metastasis of the gastric cancer incl. AEG and Krukenberg
tumors
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%
11.Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min
12.Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN
13.Active vaccination within 6 weeks prior to randomisation
14.Active hepatitis B or C infection
15.Female patients who are pregnant or breast feeding
16.Fertile female patients (defined as women with less than a 12-month elapse after the last menstruation) not using an acceptable form of contraception during the trial
17. Missing of capacity to contract
18.contraindication to the drugs which are used in the trial
19.Participation in another therapeutic clinical trial
20. Persons institutionalised due to regulatory actions ore by court order.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is overall survival.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures are safety (30 days complication-rate), time to progress, time to other distant metastases, quality of life (EORTC QLQ-30, STO 22). Furthermore, secondary endpoints are the frequency of toxicity and adverse events, the frequency of necessary secondary surgical procedures and the length of hospitalisation.

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