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

Phase 1

Conditions: Peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
MedDRA version: 20.0Level: LLTClassification code 10042080Term: Stomach cancerSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10042081Term: Stomach cancer in situSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2006-006088-22-DE

Lead Sponsor: Klinik für Chirurgie, Charité Campus Virchow-Klinikum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br><br>;Secondary Objective: Secondary objectives are the evaluation of:<br>1. safety problems of HIPEC lasting for a short time (30-days complication rate)<br>2. time to verifiable progress of tumour<br>3. time to appearance of elsewhere localised metastases<br>4. quality of life<br>5. frequency of toxicity and adverse events<br>6. frequency of required surgical and therapeutic intervention<br>7. duration of hospitalisation<br>;Primary end point(s): Time from randomisation to death;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. for a short time safety problems of HIPEC ( 30-days complication rate)<br>2. Time to verifiable progress of tumour<br>3. Time of appearance of elsewhere localised metastases<br>4. Quality of life<br>5. frequency of toxicity and adverse events<br>6. frequency of required surgical and therapeutic intervention<br>7. Duration of hospital stay <br>;Timepoint(s) of evaluation of this end point: End of study

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