Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Conditions
Gastric Cancer - Peritoneal Carcinomatosis
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HIPEC with mytomycin and cisplatin Type: Drug
Name: Diagnostic laparoscopy one year after gastrectomy Type: Procedure
Overall Status
Recruiting
Summary
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.

Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.

In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.

A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University of Tuebingen
Tuebingen, BW, Germany
Status: Recruiting
Contact: Derek Zieker, MD
Start Date
September 2012
Completion Date
September 2020
Sponsors
PD Dr. Derek Zieker
Source
University Hospital Tuebingen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page