[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422939":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Hallym University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","ACTIVE_COMPARATOR","Standard adjuvant XELOX 8 cycles\n\nOxaliplatin: 130 mg\u002Fm2\u002Fday(day 1) Capecitabine: 2,000 mg\u002Fm2\u002Fday(day 1-14), q 3weeks, total 8 cycles",[13,14],"Drug: Oxaliplatin","Drug: Capecitabine",{"label":16,"type":17,"description":18,"interventionNames":19},"Study arm","EXPERIMENTAL","Adjuvant XELOX 4 cycles followed by capecitabine monotherapy 4 cycles\n\nOxaliplatin: 130 mg\u002Fm2\u002Fday(day 1) Capecitabine: 2,000 mg\u002Fm2\u002Fday(day 1-14), q 3weeks, 4 cycles\n\nfollowed by\n\nCapecitabine: 2,000 mg\u002Fm2\u002Fday(day 1-14), q 3weeks, 4 cycles",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oxaliplatin","Oxaliplatin: 130 mg\u002Fm2\u002Fday",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Capecitabine","Capecitabine: 2,000 mg\u002Fm2\u002Fday",[9,16],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bum Jun Kim, Dr","CONTACT","82-31-380-3704","getwisdom1025@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Gyeonggi-do","South Korea",{"type":43,"coordinates":44},"Point",[45,46],126.76917,37.58944,{"lat":46,"lon":45},[49],{"name":50,"role":34,"phone":35,"phoneExt":26,"email":36},"Bum Jun Kim",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zang, Dae Young","Principal Investigator","100422939","phase-3-optimal-duration-of-oxaliplatin-in-adjuvant-xelox-for-gastric-cancer-patients-exodox-100422939",false,"NCT04787354","Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)","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\u002FIII Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)\n* Pathologically confirmed stage II, III patients (AJCC 8th edition)\n* Age 19 years and older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2\n* Adequate marrow function (ANC \\> 1,500\u002FuL, Platelet \\>100,000\u002FuL, Hb \\> 8.0 g\u002FdL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study)\n* Adequate renal function, with serum creatinine \\\u003C 1.5 x upper limit of normal (ULN).\n* Adequate hepatic function with serum total bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN\n* Written, informed consent to the study\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile)\n* Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug\n* Evidence of metastasis (including cytologically confirmed malignant ascites)\n* Prior systemic chemotherapy or radiation therapy for stomach cancer\n* Patients who have not recovered from serious complications of gastrectomy\n* 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)\n* 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\n* 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)\n* Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug\n* Serious uncontrolled infection or other serious uncontrolled disease\n* History of allograft requiring immunosuppression therapy\n* Received any investigational drug or procedure within 4 weeks prior to randomization\n* Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU\u002FmL, and are allowed to use prophylactic antiviral agents by investigator's choice)\n* Active HIV infection\n* Patients with peripheral sensory neuropathy with functional impairment","ALL","19 Years",{"count":65,"type":66},976,"ESTIMATED","INTERVENTIONAL",[69],"PHASE3","This study aims to compare the efficacy and safety of reduced adjuvant XELOX treatment (4 cycles of XELOX followed by 4 cycles of capecitabine alone) to standard adjuvant XELOX treatment (8 cycles of XELOX).",[72],"Gastric Cancer",[74,75,23,28],"Stomach Neoplasms","Chemotherapy, Adjuvant","2022-02-04",{"date":78,"type":79},"2022-02-21","ACTUAL",{"date":81,"type":79},"2021-11-01",{"date":83,"type":66},"2027-12-31",{"name":5,"class":6},1]