Status:
RECRUITING
Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)
Lead Sponsor:
Hallym University Medical Center
Conditions:
Gastric Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
XELOX (oxaliplatin + capecitabine) combination chemotherapy is considered a standard adjuvant treatment for curatively resected gastric cancer patients after it proved its effecacy in the CLASSIC tria...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
976 Patients enrolled
Trial Details
Trial ID
NCT04787354
Start Date
November 1 2021
End Date
December 31 2027
Last Update
February 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hallym University Medical Center
Gyeonggi-do, South Korea