Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Study Overview
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Brief Summary
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Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease. The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared. The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.

Detailed Description
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To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.

Official Title
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Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: cisplatin, Fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DISEASE CHARACTERISTICS Histologically confirmed primary adenocarcinoma of the stomach 3-4weeks after radical operation for gastric cancer Stage of the gastric cancer was T3-4NxM0 PATIENT CHARACTERISTICS: Age: 18 - 70years old Life expectancy: Longer than 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 80*10^12/mm3 Hepatic: - AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy and radiotherapy were not allowed No other concurrent chemotherapy Radiotherapy: Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed Surgery: See Disease Characteristics Prior surgery for gastric cancer was necessary Exclusion Criteria: Haven't recovery from operation or complication of operation With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) Pregnant or nursing Other currently active malignancy except nonmelanoma skin cancer Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine metastasis before enrollment Received other chemotherapy or radiotherapy after operation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control arm<br>adjuvant intravenous system chemotherapy | |
| Experimental: IP Chemo arm<br>adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy | Drug: cisplatin, Fluorouracil<br>* cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times<br>* Other names: DDP,5-Fu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastasis in Peritoneum and peritoneal cavity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver metastasis |  | 1 year | 
| Refraction-free survival |  | 1 year | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer