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

Sponsor
Min-Hee Ryu (Other)
Overall Status
Completed
CT.gov ID
NCT01671449
Collaborator
(none)
338
Enrollment
9
Locations
2
Arms
34
Duration (Months)
37.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Drug: S-1
S-1 : 40 mg/m2, twice daily, Day 1-14
Other Names:
  • TS-1

    • Drug: Cisplatin
    60 mg/m2/day Day 1
    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

    Drug: S-1
    S-1 : 40 mg/m2, twice daily, Day 1-14
    Other Names:
  • TS-1

    • Drug: Oxaliplatin
    130 mg/m2/day Day 1
    Other Names:
  • Pleoxin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [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.

    Secondary Outcome Measures

    1. Overall survival [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.

    2. Response rate [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.

    3. Quality of life [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.

    4. Number of Adverse Events [Every 3 weeks]

      Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    1. 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

    2. 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

    1. 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

    1. Participation to other clinical trials or administration of other investigational drugs within 30 days before the randomisation

    2. Pregnant or lactating women

    3. 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

    4. Ineligible for the study at the discretion of investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do Korea, Republic of 361-711
    2 Seoul National University Bundang Hospital Bundang-gu, Seongnam-si Gyeonggi-do Korea, Republic of 463-707
    3 National Cancer Center Ilsan Gyeonggi-do Korea, Republic of
    4 Chonnam National University Hwasun Hospital Hwasun-eup, Hwasun-gun Jeollanam-do Korea, Republic of 519-763
    5 Dongnam Institute of Radiological and Medical Sciences Busan Korea, Republic of 619-953
    6 Yeungnam University Medical Center Daegu Korea, Republic of 705-717
    7 Gangneung Asan Hospital Gangneung-si Korea, Republic of 210-711
    8 Seoul St. Mary's hospital of the Catholic University of Korea Seoul Korea, Republic of 137-701
    9 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Min-Hee Ryu

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Min-Hee Ryu, Asan Medical Center, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT01671449
    Other Study ID Numbers:
    • AMC-ONCGI-1202
    First Posted:
    Aug 23, 2012
    Last Update Posted:
    Nov 30, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Min-Hee Ryu, Asan Medical Center, Asan Medical Center
    Gastric cancer
    S-1
    Cisplatin
    Oxaliplatin
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Nov 30, 2015