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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Oxaliplatin

    Drug

    Oxaliplatin: 130 mg/m2/day

  • Capecitabine

    Drug

    Capecitabine: 2,000 mg/m2/day

Treatment groups

976 Participants
are divided into 2 treatment groups
Group A: Control armActive comparator 2 interventions
Group B: Study armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

disease-free survival

The disease-free survival (DFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause

Time frame
3-year

Secondary outcomes

1

overall survival

The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method

Time frame
5-year
2

Toxicity profiles

Adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 5.0

Time frame
3-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hallym University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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