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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-11-008 | Other Identifier | Samsung Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX_12 or CAPOX_8 | Active Comparator | 6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX |
|
| FOLFOX_6 or CAPOX_4 | Experimental | 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years | |
| quality of life | 3 years | |
| safety profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Suk Park, M.D.,Ph.D. | Samsung Medical Center, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang-si | Gyeonggi-do | 431-070 | South Korea | ||
| Soon Chun Hyang University Hospital Bucheon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35772045 | Derived | Kim ST, Kim SY, Lee J, Yun SH, Kim HC, Lee WY, Kim TW, Hong YS, Lim SB, Baek JY, Oh JH, Ahn JB, Shin SJ, Han SW, Kim SG, Kang SY, Sym SJ, Zang DY, Kim YH, Choi IS, Kang JH, Kim MJ, Park YS. Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07. J Clin Oncol. 2022 Nov 20;40(33):3868-3877. doi: 10.1200/JCO.21.02962. Epub 2022 Jun 30. |
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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.
| 3 years |
| Bucheon-si |
| Gyeonggi-do |
| 420-767 |
| South Korea |
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-768 | South Korea |
| School of Medicine, CHA University | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
| Sungkyunkwan University Masan Samsung Hospital | Masan | Gyeongsangnam | 630-522 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam | 626-770 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam | 519-809 | South Korea |
| Kosin Medical Center | Busan | 602-702 | South Korea |
| Dong-A University Medical Center | Busan | 602-715 | South Korea |
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Seoul St. Mary's hospital, Catholic Univerisity | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Soonchunhyang University Hospital | Seoul | 140-210 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Chung-Ang University College of Medicine | Seoul | 156-755 | South Korea |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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