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

November 26, 2015 updated by: Min-Hee Ryu

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 619-953
        • Dongnam Institute of Radiological and Medical Sciences
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam University Medical Center
      • Gangneung-si, Korea, Republic of, 210-711
        • Gangneung Asan Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 137-701
        • Seoul St. Mary's Hospital of the Catholic University of Korea
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Ilsan, Gyeonggi-do, Korea, Republic of
        • National Cancer Center
    • Jeollanam-do
      • Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of randomization to death from any cause, assessed up to 3 years
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.
Every 6 weeks
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.
Every 6 weeks
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.
Every 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-ONCGI-1202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on S-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe