Status:
COMPLETED
Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer: SOS
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Kyungpook National University Hospital
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combinati...
Detailed Description
The primary endpoint of this study is Progression Free Survival (PFS). It is defined as the time from the date of randomization to the time of disease progression as assessed by the investigators, or ...
Eligibility Criteria
Inclusion
- Histologically documented metastatic or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 to 74 years old
- Performance status (ECOG scale) 0-2
- No significant problems for oral intake and drug administration
- At least one measurable or evaluable disease defined by RECIST
- Adequate bone marrow function (ANC ≥ 1,500/uL, Platelet ≥ 100,000/ uL, Hb ≥ 9.0 g/dl)
- Adequate renal function: serum creatinine ≤ UNL (if serum creatinine \> UNL, creatinine clearance should be ≥ 60 mL/min)
- Adequate hepatic function (Total bilirubin \< 2 x UNL and AST/ALT levels \< 3 x UNL without liver metastasis,total bilirubin \< 3x ULN and AST/ALT levels \< 5 x UNL with liver metastasis)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study) and cisplatin was not used before
- Patients should sign a written informed consent before study entry
Exclusion
- Tumor type other than adenocarcinoma
- Previously exposed to any fluropymidine within 6 months before the study
- Previously exposed to Platinum therapy regardless of its period and/or duration
- Microscopic residual disease only after noncurative gastrectomy with R1 resection (resection margin positive)
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
- Presence of CNS metastasis
- Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery (patient received curative operation or RFA for metastatic disease)
- Serious illness or medical conditions:
- Congestive heart failure (NYHA class III or IV)
- Unstable angina or myocardial infarction within the past 12 months
- Significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- Uncontrolled hypertension
- Hepatic cirrhosis (≥ Child class B)
- Interstitial pneumonia
- Pulmonary adenomatosis
- Psychiatric disorder that may interfere with protocol compliance
- Unstable diabetes mellitus
- Uncontrolled ascites or pleural effusion
- Active infection
- Receiving a concomitant treatment interacting with S-1 or cisplatin:
- Flucytosine (a fluorinated pyrimidine antifungal agent)
- Antivirals such as sorivudine, ramivudine, brivudine or other chemically related agents, warfarin, phenprocoumon, phenytoin, allopurinol
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT00915382
Start Date
January 1 2009
End Date
May 1 2013
Last Update
January 7 2020
Active Locations (1)
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1
Department of Oncology, Asan Medical Center
Seoul, South Korea, 138-736