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S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer (SOPP)

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ClinicalTrials.gov Identifier: NCT01671449
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Min-Hee Ryu, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE August 17, 2012
First Posted Date  ICMJE August 23, 2012
Last Update Posted Date November 30, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2012)		 Progression-free survival [ Time Frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ]
The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
  • Overall survival [ Time Frame: From date of randomization to death from any cause, assessed up to 3 years ]
    Overall survival is defined as the time from randomization to death due to any cause.
  • Response rate [ Time Frame: Every 6 weeks ]
    Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.
  • Quality of life [ Time Frame: Every 6 weeks ]
    Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
  • Number of Adverse Events [ Time Frame: Every 3 weeks ]
    Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • Overall survival [ Time Frame: From date of randomization to death from any cause, assessed up to 3 years ]
    Overall survival is defined as the time from randomization to death due to any cause.
  • Response rate [ Time Frame: Every 6 weeks ]
    Response assessment will be performed according to RECIST criteria version 1.1 every 2 cycles (6 weeks) of treatment.
  • Quality of life [ Time Frame: Every 6 weeks ]
    Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
  • Number of Adverse Events [ Time Frame: Every 3 weeks ]
    Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer
Official Title  ICMJE Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer
Brief Summary A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: S-1
    S-1 : 40 mg/m2, twice daily, Day 1-14
    Other Name: TS-1
  • Drug: Cisplatin
    60 mg/m2/day Day 1
  • Drug: Oxaliplatin
    130 mg/m2/day Day 1
    Other Name: Pleoxin
Study Arms  ICMJE
  • Active Comparator: S-1 plus Cisplatin

    • S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)

      : If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.

    • Cisplatin: 60 mg/ m2/day, i.v., day 1
    • Every 3 weeks
    Interventions:
    • Drug: S-1
    • Drug: Cisplatin
  • Experimental: S-1 plus Oxaliplatin

    • S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)

      : If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.

    • Oxaliplatin: 130 mg/ m2/day, i.v., day 1
    • Every 3 weeks
    Interventions:
    • Drug: S-1
    • Drug: Oxaliplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2012)		 338
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent before the enrollment
  2. Age ≥18 years old
  3. Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. Patients able to swallow food and drugs
  6. At least one measurable or evaluable lesion according to RECIST criteria version 1.1

  7. Adequate bone, hepatic, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first administration of study drugs

    • Absolute neutrophil count (ANC) ≥ 1,500/ uL, platelet ≥ 100,000/ uL, haemoglobin (Hb) ≥ 9.0 g/dl,
    • Serum creatinine ≤ 1.5 mg/dL (If serum creatinine is greater than 1.5 mg/dL, creatinine clearance [Ccr] should be 60 mL/min or greater. Ccr is calculated by Cockcroft-Gault formula or 24hr urine collection)
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST/ALT levels ≤ 3.0 x ULN (AST/ALT levels ≤ 5.0 x ULN for patients with liver involvement of their cancer)
  8. In patients who received adjuvant or neoadjuvant chemotherapy, completion of systemic chemotherapy 6 months before the study enrollment, and no previous administration of platinum derivatives
  9. Estimated life expectancy of more than 3 months

Exclusion Criteria:

  1. Other histologic types than adenocarcinoma
  2. Recurrence within 24 weeks following completion of adjuvant chemotherapy
  3. R1 gastrectomy (i.e., microscopic residual disease)
  4. History of another malignancy within the last five years from the day of written informed consent except cured basal cell carcinoma of skin and cured carcinoma in situ of uterine cervix
  5. Radiotherapy within 4 weeks after randomization
  6. History of significant neurologic or psychiatric disorders, and presence or history of CNS metastasis
  7. Major surgery within 4 weeks before study entry, or insufficient recovery from major surgery (except the patients who received only open and closure or biopsy)

  8. Other serious illness or medical conditions as follows;

    • Any following conditions occurred within 6 months before study entry: myocardial infarction, severe/unstable angina, bypass surgery for coronary artery/peripheral artery, congestive heart failure (NYHA class III or IV), cerebral infarction or transient ischemic attack
    • Conduction abnormality such as 2nd degree or greater AV block or severe arrhythmia that requires medical treatments (right bundle branch block (RBBB) is eligible, but left bundle branch block (LBBB) is not.)
    • Uncontrolled hypertension
    • Liver cirrhosis (Child Pugh Class B or greater)
    • Interstitial pneumonia, pulmonary fibrosis
    • Active viral hepatitis B
    • Uncontrolled diabetes mellitus
    • Uncontrolled ascites or pleural effusion
    • Uncontrolled active infection or sepsis

  9. Administration of medications which may have potentially pharmacokinetic interaction with S-1, cisplatin, and oxaliplatin

    • Flucytosine, a fluorinated pyrimidine antifungal agent
    • Anti-viral agents, such as sorivudine, and brivudine, or chemical similar drugs
    • Warfarin (except, low dose warfarin for the purpose of prophylaxis), phenprocoumon
    • Phenytoin
    • Allopurinol
  10. Participation to other clinical trials or administration of other investigational drugs within 30 days before the randomisation
  11. Pregnant or lactating women
  12. Women or men of child bearing potential not employing adequate contraception during study treatments or until the 3 months after the end of study treatments
  13. Ineligible for the study at the discretion of investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01671449
Other Study ID Numbers  ICMJE AMC-ONCGI-1202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Min-Hee Ryu, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Min-Hee Ryu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min-Hee Ryu, M.D., Ph.D Asan Medical Center
Principal Investigator: Young-Iee Park, MD., Ph.D. National Cancer Center, Seoul, Korea
Principal Investigator: Ik-Joo Chung, MD., Ph.D. Chonnam National University Hospital
PRS Account Asan Medical Center
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP