The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

— GZH-001  

Official title:

Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02038621
• Other study ID #: 2ndSichuan
• Secondary ID: GZH-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 15, 2014
• Last updated: January 15, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2014
• Source: The Second People's Hospital of Sichuan
• Contact: Chengya Zhou, bachelor
• Phone: 86 13980972569
• Email: yaya713913[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second People's Hospital of Sichuan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	overall survival (OS)		from the date of randomization until death from any cause or up to 1 year	Yes
Secondary	adverse events (AE)		from date of randomization to 28 days after the last chemo dosage	Yes
Secondary	health-related quality of life (HRQOL		evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage	No