XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
NCT ID: NCT01798251
Last Updated: 2013-05-06
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
40 participants
INTERVENTIONAL
2012-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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XELOX-X
XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m\^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.
X Maintenance: Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.
Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Interventions
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Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Genders Eligible for Study: Both
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Histologically confirmed gastric adenocarcinoma(including LAUREN type).
* Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
* chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
* Hb \> 90g/L, neutrophil count \> or = 1.5\*10\^9/L, platelet \> or = 100\*10\^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) \< or = 2.5 times ULN, total bilirubin (TBIL) \< 1.5 times ULN, serum albumin level \> or = 30g/L, serum creatinine \< 1 times ULN.
* No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
* Able to accept oral medication
* Compliance with protocol
Exclusion Criteria
* Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
* Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
* clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
* Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
* Organ transplantation requires immunosuppressive treatment.
* Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
* Moderate or severe renal impairment(creatinine clearance (CCr) = or \< 50 ml/min), or serum creatinine \> ULN.
* Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
* Allergy to Oxaliplatin or any study medication ingredients.
65 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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BAI Yuxian
Professor
Principal Investigators
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Yuxian BAI, PhD
Role: PRINCIPAL_INVESTIGATOR
The tumor hospital of Harbin medical university
Locations
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The tumor hospital of Harbin medical university
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGOG20120101009
Identifier Type: -
Identifier Source: org_study_id
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