Status:
UNKNOWN
S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer
Lead Sponsor:
Kyungpook National University Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory res...
Detailed Description
This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by treatment with ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01426646
Start Date
September 1 2011
End Date
September 1 2016
Last Update
January 5 2012
Active Locations (2)
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1
Donga university hospital
Busan, South Korea, 602-715
2
Ulsan University Hospital
Ulsan, South Korea, 682-714