The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
NCT ID: NCT02038621
Last Updated: 2014-01-16
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
224 participants
INTERVENTIONAL
2014-01-31
2017-12-31
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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A
Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.
Paclitaxel
Oxaliplatin and Capecitabine
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.
B
Observation until progression
Paclitaxel
Oxaliplatin and Capecitabine
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.
Interventions
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Paclitaxel
Oxaliplatin and Capecitabine
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.
Eligibility Criteria
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Inclusion Criteria
* male or female
* Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
* ECOG performance status score 0-2 ;
* Expected survival time more than three months ;
* Adequate hematologic parameters and liver and kidney function ;
* Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
* Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
* Renal : serum creatinine ≤ ULN ;
* Informed consent of patients or their agents , and signed informed consent.
Exclusion Criteria
* Patients with CNS metastases
* Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
* Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
* Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
* Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
* The researchers believe that this test is not suitable for those who participate .
18 Years
ALL
No
Sponsors
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The Second People's Hospital of Sichuan
OTHER
Responsible Party
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Chengya Chou
Oncology physician
Central Contacts
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Other Identifiers
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GZH-001
Identifier Type: -
Identifier Source: secondary_id
2ndSichuan
Identifier Type: -
Identifier Source: org_study_id
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