Reducing the risk of peritoneal carcinomatosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC MedDRA version: 14.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspe
Conditions
Interventions
Trade Name: Mitomycin medac
Product Name: Mitomycin medac
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Concentration unit: mg milligram(s)
Co
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Time free of recurrence complication rate ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Time free of recurrence complication rate;Timepoint(s) of evaluation of this end point: During the routine 5-year-Follow-Up-Investigations | — |
Countries
Germany
Contacts
Public ContactCo-Investigator
University Hospital Tübingen
Outcome results
None listed