Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Phase 2

Terminated

Conditions: Gastric Cancer
Peritoneal Carcinomatosis

Interventions: Drug: positive cytology with HIPEC

Registration Number: NCT01683864

Lead Sponsor: University Hospital Tuebingen

Brief Summary: Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Detailed Description: 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\<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

Inclusion Criteria

Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
No prior chemotherapy
Patients of full age, independent of gender ECOG ≤ 2
No dissemination of the tumor confirmed by CT of the lung and the abdomen.
Signed Consent form of the Patient agreeing to investigations
Leucocytes > 3.000/µl
Thrombocytes > 100.000/µl
Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
informed consent of the patient
normal ejection-fraction of the heart

Exclusion Criteria

Dissemination of the tumor or non-resectable primary tumor
Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
Patient not of full age
Inflammatory chronic bowel disease
Inclusion of the patient in a different study
Pregnancy or lactation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
positive cytology with HIPEC	positive cytology with HIPEC	gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative

Primary Outcome Measures

Name	Time	Method
Peritoneal Carcinosis Free Survival	5 Years	Three patients were enrolled in the study. No study results because no patient has received study drug.
Disease Free Survival	5 years	No study results because no patient has received study drug.

Secondary Outcome Measures