Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
NCT ID: NCT00992199
Last Updated: 2010-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
79 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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control arm
adjuvant intravenous system chemotherapy
No interventions assigned to this group
IP Chemo arm
adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Interventions
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cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Fudan University Cancer Hospital
Principal Investigators
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Jin Li, MD
Role: PRINCIPAL_INVESTIGATOR
member of Fudan University Cancer Hospital
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IP chemo-AGC
Identifier Type: -
Identifier Source: org_study_id