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

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT02560974
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

Inclusion Criteria

• Adult participants greater than or equal to (>=) 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

• Serious concomitant medical illnesses that would limit life expectancy to less than (<) 5 years
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
• Any evidence of metastatic disease (including presence of tumor cells in the ascites)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine + Oxaliplatin	Oxaliplatin	Patients will receive oral capecitabine (1000 mg/m\^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m\^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).
Capecitabine + Oxaliplatin	Capecitabine	Patients will receive oral capecitabine (1000 mg/m\^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m\^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).

Primary Outcome Measures

Name	Time	Method
Disease-free survival rate	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years
Incidence of adverse events	5 years