Status:
UNKNOWN
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
Lead Sponsor:
Fudan University
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 diagnos...
Detailed Description
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00992199
Start Date
August 1 2009
End Date
December 1 2011
Last Update
September 8 2010
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032