Overview

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Status:
Terminated

Trial end date:
2015-05-01

Target enrollment:
0

Participant gender:
All

Summary

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

PD Dr. Derek Zieker
University Hospital Tuebingen

Treatments:

Cisplatin

Criteria

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