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Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer

Primary Purpose

Elderly, S-1, Oxaliplatin

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
S-1 (TS-1) and Oxaliplatin (Oxalitin)
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly focused on measuring elderly, S-1, Oxaliplatin, relapsed or metastatic gastric cancer

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age : more than 70 to 80 and ECOG PS 0-2
  • Age : more than 65 to less than 70 and ECOG PS 2
  • Histological or pathologically confirmed adenocarinoma
  • Relapsed or metastatic adenocarcinoma of stomach
  • No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
  • At least more than one measurable lesion on RECIST criteria
  • No radiation history for the target lesion
  • An estimated life expectancy of more than 3 months
  • Ability for adequate oral intake
  • Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL.
  • Adequate renal function: defined as Creatinine <1.5mg/dL.
  • Adequate hepatic function: defined as total bilirubin < 2.0mg/dL, SGOT/SGPT < normal x 3.
  • Written informed consent

Exclusion Criteria:

  • Symptomatic brain metastasis or meningeal metastasis.
  • Double primary cancer
  • Medical history of other cancer within 5 years
  • G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
  • Hypersensitivity to the 5-FU or oxaliplatin
  • Active infectious disease that need to treat systemically
  • Serious medical or psychologic condition: newly developed AMI ( within 6Ms)…

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC

    Secondary Outcome Measures

    To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen

    Full Information

    First Posted
    August 17, 2009
    Last Updated
    August 17, 2009
    Sponsor
    Soonchunhyang University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00961077
    Brief Title
    Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
    Official Title
    A Prospective Phase II Study of Attenuated S-1 and Oxaliplatin(Attenuated SOX) as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    August 2011 (Anticipated)
    Study Completion Date
    August 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Soonchunhyang University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC
    Detailed Description
    Treatment scheme S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours Each cycle is repeated every 3 weeks Response evaluation will be performed every 2 cycles Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elderly, S-1, Oxaliplatin, First-Line, Gastric Cancer
    Keywords
    elderly, S-1, Oxaliplatin, relapsed or metastatic gastric cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    S-1 (TS-1) and Oxaliplatin (Oxalitin)
    Intervention Description
    S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours every 3 weeks
    Primary Outcome Measure Information:
    Title
    To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
    Time Frame
    every 2 cycles
    Secondary Outcome Measure Information:
    Title
    To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
    Time Frame
    every 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age : more than 70 to 80 and ECOG PS 0-2 Age : more than 65 to less than 70 and ECOG PS 2 Histological or pathologically confirmed adenocarinoma Relapsed or metastatic adenocarcinoma of stomach No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment At least more than one measurable lesion on RECIST criteria No radiation history for the target lesion An estimated life expectancy of more than 3 months Ability for adequate oral intake Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL. Adequate renal function: defined as Creatinine <1.5mg/dL. Adequate hepatic function: defined as total bilirubin < 2.0mg/dL, SGOT/SGPT < normal x 3. Written informed consent Exclusion Criteria: Symptomatic brain metastasis or meningeal metastasis. Double primary cancer Medical history of other cancer within 5 years G-I bleeding or intestinal obstruction (other condition that can't have the oral intake) Hypersensitivity to the 5-FU or oxaliplatin Active infectious disease that need to treat systemically Serious medical or psychologic condition: newly developed AMI ( within 6Ms)…
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sang-Cheol Lee, M.D.
    Organizational Affiliation
    Soonchunhyang University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer

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