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S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy (SOHUG)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02191566
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Dong-Hoe Koo, Kangbuk Samsung Hospital

Brief Summary:
After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: S-1 (452500ACH) Drug: OXALIPLATIN (205803BIJ) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection
Study Start Date : November 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: S-1/Oxaliplatin
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Drug: S-1 (452500ACH)
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
Other Name: TS-1 (tegafur+gimeracil+oteracil)

Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Other Name: PLEOXTIN (645402430)

Primary Outcome Measures :
  1. 3-year recurrence-free survival, RFS [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. 5-year overall survival, OS [ Time Frame: 5-year ]

Other Outcome Measures:
  1. Toxicity will be graded according to the CTCAE. [ Time Frame: 1-year ]
    For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF.

  2. compliance for chemotherapy [ Time Frame: 1-year ]
    Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who voluntarily provide written informed consent prior to entering into this study
  • Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
  • Patients who underwent radical resection with wide lymph node dissection
  • TNM stage (6th AJCC) of IIIB or IV on post-operative staging
  • Patients who can be randomized within 6 weeks after surgery

Exclusion Criteria:

  • Aged < 20 years or ≥ 76 years
  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Patients who underwent surgery for neoplasm in stomach in the past
  • History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
  • Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
  • Residual cancer on post-operative staging (R1 and R2 resection)
  • Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
  • Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
  • Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
  • Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
  • History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

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): NCT02191566

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Korea, Republic of
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 110-746
Contact: Dong-Hoe Koo, MD,PhD    +82-2-2001-8330   
Sponsors and Collaborators
Kangbuk Samsung Hospital
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Principal Investigator: Dong Hoe Koo, MD,PhD Kangbuk Samsung Hospital

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Responsible Party: Dong-Hoe Koo, Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital Identifier: NCT02191566    
Other Study ID Numbers: GA01 Version 1.0 (KBC14078)
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Keywords provided by Dong-Hoe Koo, Kangbuk Samsung Hospital:
Stomach 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
Antineoplastic Agents