Trial Information

Summary: A Study of Xeloda (Capecitabine) in Combination Chemotherapy Versus Surgery Alone in Patients With Gastric Cancer

Status: Recruiting

Protocol Number: MO17527

Sponsor: Roche Korea

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label study comparing the effect of adjuvant chemotherapy with Xeloda/oxaliplatin versus surgery alone on survival in patients with stage II, IIIa and IIIb gastric cancer.

Brief Summary: This study will compare Xeloda/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive patients who have undergone potentially curative resection for gastric cancer. Patients will be randomized to either the chemotherapy arm or the observation arm. Xeloda will be administered orally, 1000mg/m² twice daily on days 1-15 of a 3 week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous infusion, 130mg/m² every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 500+ individuals. Target sample size is 1024.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Gastric Cancer

Intervention Type: Drug

Intervention Name: capecitabine[Xeloda]

Primary Outcome: 1. 3 year disease-free survival rate.

Key Secondary Outcomes: 1. Efficacy: Overall survival. Safety: AEs, labs.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2006

Trial Registration Date: 05/04/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:27:50 PM