Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
NCT ID: NCT00591045
Last Updated: 2008-01-11
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
263 participants
INTERVENTIONAL
2008-01-31
2012-12-31
Brief Summary
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Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
mFOLFOX
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
2
No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.
No interventions assigned to this group
Interventions
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mFOLFOX
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
Eligibility Criteria
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Inclusion Criteria
* Ambulatory males or females, aged 30-70 years.
* Histologically confirmed gastric adenocarcinoma, staged preoperatively AJCC/UICC stage III(T3N1,T2N2,T4N0,T3N2)and IVM0 and operable
* Life expectancy more than 3 months
* Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
* Normal hepatic, renal, and bone marrow function (GPT\<2 fold of upper limit value; WBC\>4000/dl, Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value)
Exclusion Criteria
* Pregnant or lactating women or women do not agree conceptive procedures.
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
* History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
* Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
* Organ allografts requiring immunosuppressive therapy.
* Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
* Moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN).
* Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Hypersensitivity to platinum compounds or any of the components of the study medications.
* Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
* Unwilling or unable to comply with the protocol for the duration of the study.
30 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Capital Medical University
OTHER
Peking University
OTHER
Responsible Party
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Peking University
Principal Investigators
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Jiafu Ji, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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Peking University School of Oncology
Beijing, Beijing 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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CGCCG-0701
Identifier Type: -
Identifier Source: org_study_id
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