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Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Phase 2/Phase 3
18 Years
Open (Enrolling)
Gastric Cancer, Peritoneal Carcinomatosis

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Trial Information

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0

2. No prior chemotherapy

3. Patients of full age, independent of gender ECOG ≤ 2

4. No dissemination of the tumor confirmed by CT of the lung and the abdomen.

5. Signed Consent form of the Patient agreeing to investigations

6. Leucocytes > 3.000/µl

7. Thrombocytes > 100.000/µl

8. Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min

9. informed consent of the patient

10. normal ejection-fraction of the heart

Exclusion Criteria:

1. Dissemination of the tumor or non-resectable primary tumor

2. Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of
the cervix and appropriately treated basal cell carcinoma of the skin)

3. Patient not of full age

4. Inflammatory chronic bowel disease

5. Inclusion of the patient in a different study

6. Pregnancy or lactation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Peritoneal carcinosis free survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Alfred Königsrainer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Tuebingen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

September 2012

Completion Date:

September 2020

Related Keywords:

  • Gastric Cancer
  • Peritoneal Carcinomatosis
  • Stomach Neoplasms
  • Carcinoma