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

November 1, 2016 updated by: Hoffmann-La Roche

A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1035

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
      • Beijing, China, 100142
      • Fujian, China, 350001
      • Guangzhou, China, 510060
      • Guangzhou, China, 510080
      • Shanghai, China, 200032
      • Shanghai, China, 200025
      • Shenyang, China, 110001
      • Tianjin, China, 300060
  • Korea, Republic of
      • Bundang City, Korea, Republic of, 463-802
      • Busan, Korea, Republic of, 49267
      • Daegu, Korea, Republic of
      • Daegu, Korea, Republic of, 702-210
      • Daegu, Korea, Republic of, 700-712
      • Gyeonggi-do, Korea, Republic of, 443-380
      • Gyeonggi-do, Korea, Republic of, 10408
      • Incheon, Korea, Republic of, 405-760
      • Jeollabuk-do, Korea, Republic of, 561-712
      • Jeollanam-do, Korea, Republic of, 58128
      • Seoul, Korea, Republic of, 139-709
      • Seoul, Korea, Republic of, 158-710
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-720
      • Seoul, Korea, Republic of, 130-872
      • Seoul, Korea, Republic of, 134-791
      • Seoul, Korea, Republic of, 152-703
      • Seoul, Korea, Republic of, 140-743
      • Suwon, Korea, Republic of
  • Taiwan
      • Changhua, Taiwan, 500
      • Tainan, Taiwan, 704
      • Taipei, Taiwan
      • Taipei, Taiwan, 104
      • Taipei, Taiwan, 00112
      • Taoyuan, Taiwan, 333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capecitabine + 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).
Drug: Capecitabine
Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
Other Names:
  • Xeloda
Drug: Oxaliplatin
Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles.
No Intervention: Observation
Participants will not receive any treatment but will be seen regularly by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival rate
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Incidence of adverse events
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO17527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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