The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
Conditions
Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel Type: Drug
Name: Oxaliplatin and Capecitabine Type: Drug
Overall Status
Not yet recruiting
Summary
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 .
Location
Start Date
January 2014
Completion Date
December 2017
Sponsors
The Second People's Hospital of Sichuan
Source
The Second People's Hospital of Sichuan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page