Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer
Summary
Primary:
- To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to observation alone in terms of 3 year disease-free survival (DFS) rate in chemotherapy-naïve patients who underwent potentially curative resection for gastric cancer.
Secondary:
- To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin adjuvant therapy.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Stomach Neoplasms
Intervention
Capecitabine, Oxaliplatin
Location
Sanofi-Aventis
Beijing
China
Status
Active, not recruiting
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00411229
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Stomach Neoplasms
Tumors or cancer of the STOMACH.
Linitis Plastica
A condition where the stomach wall becomes thickened, rubbery and loses its ability to distend. The stomach assumes a "leather bottle" shape. It is most often seen in adenocarcinoma of the stomach. The term is often used synonymously with diffuse adenocarcinoma of the stomach.
Neoplasms By Site
A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.
Sizofiran
A beta-D-glucan obtained from the Aphyllophoral fungus Schizophyllum commune. It is used as an immunoadjuvant in the treatment of neoplasms, especially tumors found in the stomach.
Stomach Diseases
Pathological processes involving the STOMACH.
Clinical Trials
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