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).
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 trial. Adjuvant XELOX chemotherapy is a long-term treatment with a total treatment period of 6 months and it is known that about 33% of patients cannot complete treatment schedule due to side effects. In particular, peripheral neuropathy, which is caused by the cumulative administration of oxaliplatin, is a major cause of lowering the patient's quality of life and treatment compliance, and it is known that the incidence rate increases when standard XELOX treatment is continued for more than 6 cycles. In colorectal cancer, clinical studies have been actively conducted to shorten the duration of standard adjuvant chemotherapy to reduce the peripheral sensory neuropathy caused by oxaliplatin, but there are no relevant studies in gastric cancer. 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
976
Oxaliplatin: 130 mg/m2/day
Capecitabine: 2,000 mg/m2/day
Hallym University Medical Center
Gyeonggi-do, South Korea
RECRUITINGdisease-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
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
Toxicity profiles
Adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 5.0
Time frame: 3-year
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