Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
NCT ID: NCT00568529
Last Updated: 2010-05-26
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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SUSPENDED
PHASE2
30 participants
INTERVENTIONAL
2007-10-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combine Chemotherapy
XELOX(Xeloda and oxaliplatin combination)
Capecitabine and Oxaliplatin
Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
Interventions
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Capecitabine and Oxaliplatin
Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
* ECOG performance status ≤1
* Measurable diseases according to the RECIST
* Relapse or refractory after the first-line chemotherapy
* Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
Exclusion Criteria
* Have used any of drugs in the regimen in first-line chemotherapy
* Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Received other chemotherapy regimen after metastasis
* Participated in other clinical trials.
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, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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XELOX-AGC
Identifier Type: -
Identifier Source: org_study_id
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