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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


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

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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

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