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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

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

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