Advanced Gastric Cancer
Conditions
Keywords
intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer
Brief summary
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
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.
Interventions
DRUGcisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastasis in Peritoneum and peritoneal cavity | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Liver metastasis | 1 year |
| Refraction-free survival | 1 year |
| Overall survival | 1 year |
Countries
China
Contacts
Primary ContactJin Li, MD
Backup Contactxiaodong Zhu, MD
Outcome results
None listed