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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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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

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