Colon Cancer
Conditions
Keywords
Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy
Brief summary
This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Detailed description
This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.
Interventions
DRUGoxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Curatively resected, histologically confirmed colon adenocarcinoma * AJCC/UICC high-risk stage II, stage III colon cancer * Age over 18 years old * Performance status (ECOG scale): 0-1 * Adequate major organ functions * Patients should sign a written informed consent before study entry
Exclusion criteria
* Colon cancer other than adenocarcinoma * Rectal cancer * R1 or R2 resections * Other malignancies within the last 5 years * Symptomatic peripheral sensory neuropathy * Presence of other serious disease * Lactating or pregnant women * Fertile women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | — |
| quality of life | 3 years | — |
| safety profiles | 3 years | Safety will be assessed on the basis of an analysis of adverse events, standard clinical chemistry and hematology findings. Clinical and laboratory toxicities/symptoms will be graded according to the CTCAE 3.0. Adverse events which are not reported in CTCAE 3.0 will be graded as mild, moderate, severe or life threatening. |
Countries
South Korea
Outcome results
None listed