Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

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

Detailed Description
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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.

Official Title
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Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Conditions
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Gastric Cancer, Peritoneal Carcinomatosis

Intervention / Treatment
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* Drug: positive cytology with HIPEC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positive cytology with HIPEC<br>gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative | Drug: positive cytology with HIPEC<br>* HIPEC with mytomycin and cisplatin<br>* Other names: mytomycin and cisplatin;|
| No Intervention: positive cytology without HIPEC<br>gastric cancer cytology positive without HIPEC | |
| No Intervention: negative cytology without HIPEC<br>gastric cancer with negative cytology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal Carcinosis Free Survival | Three patients were enrolled in the study. No study results because no patient has received study drug. | 5 Years | 
| Disease Free Survival | No study results because no patient has received study drug. | 5 years |