Status and phase
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About
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
Patients with active (significant or uncontrolled) gastrointestinal bleeding
Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
Prior and/or current history of peripheral neuropathy
Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
History of or current brain metastases
Psychiatric disorder that would preclude compliance
Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
Subjects with reproductive potential not willing to use an effective method of contraception
Lactating women
Known dihydropyrimidine dehydrogenase deficiency
Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
Major surgery within 4 weeks of start of study treatment, without complete recovery
Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity
Primary purpose
Allocation
Interventional model
Masking
198 participants in 2 patient groups
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Central trial contact
Sook Ryun Park, M.D.; Se Youn Jang, M.S.
Data sourced from clinicaltrials.gov
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