Study for prevention of peritoneal carcinomatosis in patients with stomach cancer - HIPEC_Stomach

Conditions: Reducing the risk of peritoneal carcinomatosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC
MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004405-25-DE

Lead Sponsor: niversity Hospital Tübingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.histologically confirmed Adenocarcinoma of the stomach: uT2, uT3, all N, M0
2.no previous cytostatic chemotherapy
3.Both genders (female and male patients)
4.Age > 18. Patients to be at an age where reproduction is possible have to practice reliable methods of contraceptions („Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals [CPMP/ICH/286/95 mod]) during the study until 3 month after study participating. Female subjects will only be included if they have negative pregnancy test during screening.
5.ECOG = 2
6.No distant metastasis after CT in lung and abdomen, in clinical suspicion exclusion of bone metastasis with bone scintigraphy or MRI
7.Leucozytes > 3.000/µl
8.Thrombozytes > 100.000/µl
9.Serum creatinine = 1.5x of standard value, or Creatinine-Clearance > 60 ml/min
10.Written informed consent obtained prior to study entry
11.Normal ejektion fraction in echocardiography prior to therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Distant metastasis, and any non-resectable stadium
2.Hypersensitivity, contraindications for 5-FU, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin oder Docetaxel (see SmPC)
3.Active Coronary Heart Disease, Cardiomyopathy or Heart failure (NYHA stadium III-IV)
4.malignant secondary disease < 5 years ago (exception: cervical In-situ-Carcinoma, adequate treated Basal cell carcinoma
5.any major internal secundary disease or acute infections
6.Polyneuropathy > NCI Grade II
7.severe hepatic disfunction (AST/ALT > 3,5xULN, AP > 6xULN, Bilirubin > 1,5xULN)
8.Inflammatory bowel disease
9.Participation in another clinical study
10.Pregnancy or lactation period

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC;Secondary Objective: Overall survival<br>Time free of recurrence<br>complication rate<br>;Primary end point(s): progression of peritoneal carcinomatosis after following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC;Timepoint(s) of evaluation of this end point: Laparoscopy 12 month after Gastrectomy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival<br>Time free of recurrence<br>complication rate;Timepoint(s) of evaluation of this end point: During the routine 5-year-Follow-Up-Investigations