S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer
NCT ID: NCT01671449
Last Updated: 2015-11-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
338 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-12-31
Study Completion Date
2015-10-31
Brief Summary
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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
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Conditions
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Gastric Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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
Group Type
ACTIVE_COMPARATOR
S-1
Intervention Type
DRUG
S-1 : 40 mg/m2, twice daily, Day 1-14
Cisplatin
Intervention Type
DRUG
60 mg/m2/day Day 1
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
Group Type
EXPERIMENTAL
S-1
Intervention Type
DRUG
S-1 : 40 mg/m2, twice daily, Day 1-14
Oxaliplatin
Intervention Type
DRUG
130 mg/m2/day Day 1
Interventions
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S-1
S-1 : 40 mg/m2, twice daily, Day 1-14
Intervention Type
DRUG
Cisplatin
60 mg/m2/day Day 1
Intervention Type
DRUG
Oxaliplatin
130 mg/m2/day Day 1
Intervention Type
DRUG
Other Intervention Names
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TS-1
Pleoxin
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Min-Hee Ryu
OTHER
Sponsor Role
lead
Responsible Party
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Min-Hee Ryu
Asan Medical Center
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Min-Hee Ryu, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Young-Iee Park, MD., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Seoul, Korea
Ik-Joo Chung, MD., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Locations
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Seoul National University Bundang Hospital
Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Site Status
National Cancer Center
Ilsan, Gyeonggi-do, South Korea
Site Status
Chonnam National University Hwasun Hospital
Hwasun-eup, Hwasun-gun, Jeollanam-do, South Korea
Site Status
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Site Status
Dongnam Institute of Radiological and Medical Sciences
Busan, , South Korea
Site Status
Yeungnam University Medical Center
Daegu, , South Korea
Site Status
Gangneung Asan Hospital
Gangneung-si, , South Korea
Site Status
Seoul St. Mary's hospital of the Catholic University of Korea
Seoul, , South Korea
Site Status
Asan Medical Center
Seoul, , South Korea
Site Status
Countries
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South Korea
References
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Reference Type
DERIVED
Other Identifiers
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AMC-ONCGI-1202
Identifier Type: -
Identifier Source: org_study_id