Trial Information
A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Chinese Patients With Advanced Gastric Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically confirmed cancer of the stomach or gastro-oesophageal junction;
- inoperable, locally advanced or metastatic disease, not amenable to curative therapy;
- ECOG PS of 0,1 or 2.
Exclusion Criteria:
- previous chemotherapy for locally advanced or metastatic gastric cancer;
- previous platinum or anti-angiogenic therapy;
- radiotherapy within 28 days of randomisation;
- evidence of CNS metastasis at baseline.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Event driven; monitored throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
China: Ministry of Health
Study ID:
ML22367
NCT ID:
NCT00887822
Start Date:
March 2009
Completion Date:
June 2013
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms