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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Min-Hee Ryu, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01671449
First received: August 17, 2012
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: From date of randomization to death from any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization to death due to any cause.

  • Response rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.


Estimated Enrollment: 338
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671449

Contacts
Contact: Min-Hee Ryu, M.D., Ph.D. +82-2-3010-5935 miniryu@amc.seoul.kr

Locations
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
Contact: Hye-Suk Han, M.D., Ph.D.    +82-4899-7030    sook3529@hanmail.net   
Principal Investigator: Hye-Suk Han, M.D., Ph.D.         
Seoul National University Bundang Hospital Recruiting
Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin-Won Kim, M.D., Ph.D.    +82-10-2575-7055    whunt@paran.com   
Principal Investigator: Jin-Won Kim, M.D., Ph.D.         
National Cancer Center Recruiting
Ilsan, Gyeonggi-do, Korea, Republic of
Contact: Young-Iee Park, M.D., Ph.D.    +82-10-4742-9875    youngiee@ncc.re.kr   
Principal Investigator: Young-Iee Park, M.D., Ph.D.         
Chonnam National University Hwasun Hospital Recruiting
Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
Contact: Ik-Joo Chung, M.D., Ph.D.    +82-10-4602-9263    ijchung@chonnam.ac.kr   
Principal Investigator: Il-Joo Chung, M.D., Ph.D.         
Dongnam Institute of Radiological and Medical Sciences Recruiting
Busan, Korea, Republic of, 619-953
Contact: Bong-Gun Seo, M.D., Ph.D.    +82-10-2912-8628    sbg450@hanmail.net   
Principal Investigator: Bong-Gun Seo, M.D., Ph.D.         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Kyung-Hee Lee, M.D., Ph.D.    +82-10-2558-6163    lkhee@med.yu.ac.kr   
Principal Investigator: Kyung-Hee Lee, M.D., Ph.D.         
Gangneung Asan Hospital Recruiting
Gangneung-si, Korea, Republic of, 210-711
Contact: Ho-Suk Oh, M.D.    +82-10-6254-5389    hosukoh@gnah.co.kr   
Principal Investigator: Ho-Suk Oh, M.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Min-Hee Ryu, MD., Ph.D.    +82-10-5285-9492    miniryu@amc.seoul.kr   
Principal Investigator: Min-Hee Ryu, M.D., Ph.D.         
Seoul St. Mary's hospital of the Catholic University of Korea Not yet recruiting
Seoul, Korea, Republic of, 137-701
Contact: Young-Seon Hong, M.D., Ph.D.    +82-10-7320-6542    y331@catholic.ac.kr   
Principal Investigator: Young-Seon Hong, M.D., Ph.D.         
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
  More Information

Publications:
Kaufman S. 5-fluorouracil in the treatment of gastrointestinal neoplasia. N Engl J Med 1973;288:199-201

Responsible Party: Min-Hee Ryu, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01671449     History of Changes
Other Study ID Numbers: AMC-ONCGI-1202
Study First Received: August 17, 2012
Last Updated: April 19, 2013
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014