Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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