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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560974
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine Drug: Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1035 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: 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.



Primary Outcome Measures :
  1. Disease-free survival rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. Incidence of adverse events [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560974


Locations
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China
Beijing, China, 100044
Beijing, China, 100142
Fujian, China, 350001
Guangzhou, China, 510060
Guangzhou, China, 510080
Shanghai, China, 200025
Shanghai, China, 200032
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, 700-712
Daegu, Korea, Republic of, 702-210
Daegu, Korea, Republic of
Gyeonggi-do, Korea, Republic of, 10408
Gyeonggi-do, Korea, Republic of, 443-380
Incheon, Korea, Republic of, 405-760
Jeollabuk-do, Korea, Republic of, 561-712
Jeollanam-do, Korea, Republic of, 58128
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 130-872
Seoul, Korea, Republic of, 134-791
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 139-709
Seoul, Korea, Republic of, 140-743
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 158-710
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Taiwan
Changhua, Taiwan, 500
Tainan, Taiwan, 704
Taipei, Taiwan, 00112
Taipei, Taiwan, 104
Taipei, Taiwan
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02560974    
Other Study ID Numbers: MO17527
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents