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Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer

05:21 EDT 25th May 2013 | BioPortfolio

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)

View Results

Links

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.

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