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SOX as Adjuvant Chemotherapy for Resectable 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: NCT01542294
Recruitment Status : Unknown
Verified June 2016 by Lin Yang, Chinese Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2012
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: s1 Drug: Oxaliplatin Phase 1 Phase 2

Detailed Description:
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
Study Start Date : June 2011
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: treatment
Drug: s1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
Other Name: TS-1

Drug: Oxaliplatin
130mg/m2 d1 repeated every 21 days
Other Name: Eloxatin

Primary Outcome Measures :
  1. chemotherapy complete rate [ Time Frame: 6 months ]
    percentage of patients who completed eight cycles of chemotherapy

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ]
    assessed from surgery until 1 months after withdrawing from study

  2. recurrence-free survival(RFS) [ Time Frame: 3 years ]
    from the date of surgery until the occurrence of an event (relapse or death whichever came first)

  3. overall survival(OS) [ Time Frame: 3 years ]
    from the date of surgery to any cause of death

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 20-70 years
  • Histologically proven adenocarcinoma of the stomach
  • Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
  • Stage II, III (AJCC 7th edition)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • No prior chemotherapy or radiotherapy
  • Adequate bone marrow, renal, and liver function

Exclusion Criteria:

  • Any evidence of metastatic disease (including presence of tumor cells in the ascites).
  • Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  • Pregnant or lactating women.
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
  • Organ allografts requiring immunosuppressive therapy.
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

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): NCT01542294

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Department of Medical Oncology,Cancer hospital and Institute,CAMS
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Principal Investigator: Lin Yang, MD Department of Medical Oncology,Cancer Hospital and Institute,CAMS

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lin Yang, associated professor, Chinese Academy of Medical Sciences Identifier: NCT01542294     History of Changes
Other Study ID Numbers: CH-GI-020
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Lin Yang, Chinese Academy of Medical Sciences:
gastric cancer
adjuvant chemotherapy

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
Antineoplastic Agents