Trial Information
An Open-label Study of the Effect of First Line Treatment With Xeloda in Combination With Chemotherapy on Safety and Treatment Response in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-based Regimen.
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced or metastatic gastric cancer;
- ECOG <=2.
Exclusion Criteria:
- previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to
study);
- evidence of CNS metastasis;
- history of another malignancy within the last 5 years (except for successfully
treated basal cell cancer of skin, or in situ cancer of the cervix);
- clinically significant cardiac disease.
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:
Safety profile, specifically incidence of hand-foot syndrome
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Comite Etico de Investigacion Clinica
Study ID:
ML20777
NCT ID:
NCT00454636
Start Date:
February 2007
Completion Date:
May 2009
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
