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

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02191566
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
53
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: S-1 (452500ACH)
  • Drug: OXALIPLATIN (205803BIJ)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
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
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

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 Names:
  • TS-1 (tegafur+gimeracil+oteracil)

    • Drug: OXALIPLATIN (205803BIJ)
    Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
    Other Names:
  • PLEOXTIN (645402430)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3-year recurrence-free survival, RFS [3-year]

    Secondary Outcome Measures

    1. 5-year overall survival, OS [5-year]

    Other Outcome Measures

    1. Toxicity will be graded according to the CTCAE. [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Hospital Seoul Korea, Republic of 110-746

    Sponsors and Collaborators

    • Kangbuk Samsung Hospital

    Investigators

    • Principal Investigator: Dong Hoe Koo, MD,PhD, Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dong-Hoe Koo, Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT02191566
    Other Study ID Numbers:
    • GA01 Version 1.0 (KBC14078)
    First Posted:
    Jul 16, 2014
    Last Update Posted:
    Mar 27, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Dong-Hoe Koo, Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital
    Stomach Cancer
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Oxaliplatin
    Tegafur

    Study Results

    No Results Posted as of Mar 27, 2020