Trial Information
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer
Inclusion Criteria:
- adult patients, >=18 years of age;
- gastric cancer with unresectable locally advanced and/or metastatic disease;
- >=1 measurable lesion;
- ambulatory, with ECOG Performance Status >=1.
Exclusion Criteria:
- previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to
enrollment);
- clinically significant cardiac disease or myocardial infarction within last 12
months;
- CNS metastases;
- history of other malignancy within last 5 years, except for cured basal cell cancer
of the skin, or in situ cancer of the cervix.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Taiwan: Department of Health
Study ID:
ML20734
NCT ID:
NCT00436241
Start Date:
March 2007
Completion Date:
November 2010
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms