Advanced Gastric Cancer
Conditions
Brief summary
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
Interventions
DRUGPaclitaxel
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.
Sponsors
The Second People's Hospital of Sichuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * 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
* For patients allergic to capecitabine ; * 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS) | from the date of randomization until death from any cause or up to 1 year |
| adverse events (AE) | from date of randomization to 28 days after the last chemo dosage |
| health-related quality of life (HRQOL | evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage |
Contacts
Primary ContactChengya Zhou, bachelor
Outcome results
None listed