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Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable 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. Identifier: NCT00985556
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 28, 2009
Last Update Posted : October 20, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective than giving oxaliplatin together with capecitabine.

PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together with S-1 works compared to oxaliplatin given together with capecitabine in treating patients with recurrent, metastatic, or unresectable gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: capecitabine Drug: oxaliplatin Drug: tegafur-gimeracil-oteracil potassium Phase 2

Detailed Description:



  • To evaluate the time to progression in patients with recurrent or metastatic gastric cancer treated with oxaliplatin in combination with S-1 vs capecitabine.


  • To assess progression-free survival, overall response, disease-control rate, time-to-treatment failure, response duration, time to response, overall survival, safety, quality of life, pharmacogenetics, and psychologic distress/coping strategy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
  • Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.

Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer
Study Start Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
Drug: oxaliplatin
Given IV

Drug: tegafur-gimeracil-oteracil potassium
Given orally

Experimental: Arm II
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.
Drug: capecitabine
Given orally

Drug: oxaliplatin
Given IV

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Time to progression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically confirmed adenocarcinoma of the stomach
  • Unresectable advanced disease or recurrent disease after resection
  • At least one radiographically documented (CT scan or MRI) measurable or evaluable lesion in a previously non-irradiated area according to RECIST
  • No clinical evidence of brain metastases or history of other CNS disease unless adequately treated


  • ECOG performance status 0-2
  • Estimated life expectancy > 3 months
  • Hemoglobin ≥ 9 g/dL
  • White blood cell ≥ 4,000/µL
  • ANC ≥ 2,000/µL
  • Platelets ≥ 100,000/µL
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.0 times ULN if hepatic metastasis present)
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • AST/ALT ≤ 3.0 times ULN (≤ 5.0 times ULN if hepatic metastasis present)
  • Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if bone metastasis present)
  • Must have an intact gastrointestinal tract
  • Able to take oral medications
  • No medically uncontrolled severe infections or complications
  • No prior malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive cancer of the cervix
  • Not pregnant or nursing
  • No neuropathy ≥ grade 2
  • No clinically relevant heart disease
  • No evidence of past medical history or psychosocial dysfunction that contraindicates the use of an investigational drug or puts the patient at risk
  • No dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • No uncontrolled hepatitis B or C, chronic liver disease, or diabetes mellitus
  • No other evidence of inappropriate suspicious condition


  • No prior chemotherapy for advanced or recurrent disease

    • Prior adjuvant chemotherapy allowed if finished > 6 months before start of study treatment
  • No prior therapeutic radiotherapy

    • Prior palliative radiotherapy allowed if it was not done for primary, evaluable, or intraabdominal lesions
  • No prior capecitabine or oxaliplatin
  • No other concurrent chemotherapy or radiotherapy (except localized radiotherapy for pain relief)
  • No concurrent chemically related analogues, such as warfarin, phenytoin, or allopurinol
  • No concurrent steroid therapy except as follows:

    • Prophylactic use for hypersensitivity control or antiemetic purpose allowed
    • Chronic low dose of steroid (less than methylprednisolone 20 mg or equivalent dose) allowed

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 identifier (NCT number): NCT00985556

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Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyun C. Chung, MD, PhD    82-2-2019-3297   
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Hyun C. Chung, MD, PhD Yonsei University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00985556    
Other Study ID Numbers: CDR0000650368
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: September 2009
Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
adenocarcinoma of the stomach
stage IIIA gastric cancer
stage IIIB gastric cancer
stage IIIC gastric cancer
stage IV gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents