The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer

Phase 2

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Paclitaxel; Drug: Oxaliplatin and Capecitabine

• Registration Number: NCT02038621
• Lead Sponsor: The Second People's Hospital of Sichuan

Brief Summary

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Last Update Submitted: 2014-01-15
• Study First Posted: 2014-01-16
• Last Update Posted: 2014-01-16
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oxaliplatin and Capecitabine	Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.
A	Paclitaxel	Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.
B	Paclitaxel	Observation until progression
B	Oxaliplatin and Capecitabine	Observation until progression

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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