Actively Recruiting
Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)
Led by Hallym University Medical Center · Updated on 2022-02-21
976
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)
- Pathologically confirmed stage II or 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hallym University Medical Center
Gyeonggi-do, South Korea
Actively Recruiting
Research Team
B
Bum Jun Kim, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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