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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

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
Gastric Cancer Drug: S-1 Drug: Cisplatin Drug: Oxaliplatin Phase 3

Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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 Name: 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 Name: TS-1
Drug: Oxaliplatin
130 mg/m2/day Day 1
Other Name: Pleoxin



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01671449


Locations
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
Seoul National University Bundang Hospital
Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
National Cancer Center
Ilsan, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
Dongnam Institute of Radiological and Medical Sciences
Busan, Korea, Republic of, 619-953
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-717
Gangneung Asan Hospital
Gangneung-si, Korea, Republic of, 210-711
Seoul St. Mary's hospital of the Catholic University of Korea
Seoul, Korea, Republic of, 137-701
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

Publications:
Scheithauer W, Kornek G, Zek B et al. Palliative chemotherapy versus supportive care in patients with metastatic gastric cancer: A randomized trial. Second Int Conf Biol, Prev, Treatm GI Malignancy, Koln, Germany 1995;68(Abstr)
Kambe M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T. A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancers (abstr 584). Proc Am Soc Clin Oncol 1993;12;198

Responsible Party: Min-Hee Ryu, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01671449     History of Changes
Other Study ID Numbers: AMC-ONCGI-1202
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Min-Hee Ryu, Asan Medical Center:
Gastric cancer
S-1
Cisplatin
Oxaliplatin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Cisplatin
Antineoplastic Agents