RecruitingPhase 3NCT04787354

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

Sponsor

Hallym University Medical Center

Enrollment

976 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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).

Eligibility

Min Age: 19 Years

Inclusion Criteria8

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 Criteria16

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