Clinical trial · Interventional
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/III Gastric Cancer
NCT04787354CI-TRIAL-00056630recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Standard adjuvant XELOX 8 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, total 8 cycles
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Adjuvant XELOX 4 cycles followed by capecitabine monotherapy 4 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles followed by Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.