- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01426646
S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer
Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Byung Woog Kang, Professor
- Phone Number: +82-10-9216-2633
- Email: bwkang@knu.ac.kr
Study Locations
-
-
-
Busan, Korea, Republic of, 602-715
- Recruiting
- DongA University Hospital
-
Contact:
- Hyuk-Chan Kwon, Professor
-
Principal Investigator:
- Hyuk-Chan Kwon, Professor
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Ulsan, Korea, Republic of, 682-714
- Recruiting
- Ulsan University Hospital
-
Contact:
- Jin Ho Baek, Professor
-
Principal Investigator:
- Jin-Ho Baek, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-70 years
- Histologically proven adenocarcinoma of the stomach
- Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery
- Stage II, III and IV (M0)(AJCC 7th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior chemotherapy or radiotherapy
- Adequate bone marrow, renal, and liver function
Exclusion Criteria:
- Pregnant or lactating women.
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
Hypersensitivity to platinum compounds or any of the components of the study medications.
- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
Study Plan
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 |
---|---|
Experimental: S-1 treatment
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days.
Patients received a maximum of eight cycles.
|
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days.
Patients received a maximum of eight cycles.
Other Names:
|
Experimental: S-1 plus cisplatin treatment
S-1 plus cisplatin every 3 weeks, A total of eight cycles
|
S-1 plus cisplatin every 3 weeks, a total of eight cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse-free survival
Time Frame: 3 years from enrollment.
|
RFS was defined as the time from the date of surgery to relapse or death from any cause.
|
3 years from enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3 years from enrollment.
|
OS was defined as the time from the date of surgery to death from any cause.
|
3 years from enrollment.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wansik Yu, Professor, Kyungpook National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACSPGC-01
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.
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