Trial information
A Study of Xeloda (Capecitabine) in Combination Chemotherapy Versus Surgery Alone in Patients With Gastric Cancer
Status: No longer 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 type: Interventional; Treatment; Randomized; Open Label; Placebo; Parallel; Safety/Efficacy study
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:
- adult patients, >=18 years of age;
- gastric adenocarcinoma, stage II, IIIa or IIIb;
- potentially curative resection of tumor within 6 weeks prior to randomization;
- previously untreated with chemotherapy or radiotherapy.
Exclusion criteria:
None specified.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2006
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Fuzhou
- Guangzhou
- Shanghai
- Shenyang
- Tianjin
Korea, Republic of
- Bundang City
- Daegu
- Hwasun
- Jeonju
- Kyunggi Do
- Seoul
- Suwon
- Suwon City
Taiwan
- Changhua
- Tainan
- Taipei
- Taoyuan
