A Phase 3 interventional study of oxaliplatin in Colon Cancer, sponsored by Samsung Medical Center. Status unknown at 17 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 1,580 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
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.
Also known as: oxaliplatin (modified FOLFOX-6 OR CAPOX)
disease-free survival
Time frame: 3 years
overall survival
Time frame: 3 years
quality of life
Time frame: 3 years
safety profiles
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.
Time frame: 3 years
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center