Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)
ConditionGastric Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHallym University Medical Center
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Oxaliplatin
- Capecitabine
Treatment groups
976 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov