A randomized phase 3 clinical trial investigating optimal duration of oxaliplatin administration in postoperative XELOX (oxaliplatin + capecitabine) adjuvant chemotherapy for the patients with stage II/III gastric cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0006098
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1069
? Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)
? Pathologically confirmed stage II, III patients (AJCC 8th edition)
? Age 19 years and older
? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
? Adequate marrow function (ANC > 1,500/uL, Platelet >100,000/uL, Hb > 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study)
? Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN).
? Adequate hepatic function with serum total bilirubin = 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN
? Written, informed consent to the study
? Female patients who are pregnant or breast-feeding
? Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile)
? Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug
? Evidence of metastasis (including cytologically confirmed malignant ascites)
? Prior systemic chemotherapy or radiation therapy for stomach cancer
? Patients who have not recovered from serious complications of gastrectomy
? History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer)
? A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake
? Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction)
? Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug
? Serious uncontrolled infection or other serious uncontrolled disease
? History of allograft requiring immunosuppression therapy
? Received any investigational drug or procedure within 4 weeks prior to randomization
? Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator’s choice)
? Active HIV infection
? Patients with peripheral sensory neuropathy with functional impairment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year disease-free survival rate
- Secondary Outcome Measures
Name Time Method 5-year overall survival rate;patient-reported outcomes;Economic feasibility (cost effectiveness) evaluation