Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
NCT ID: NCT01092481
Last Updated: 2019-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1580 participants
INTERVENTIONAL
2010-01-26
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFOX_12 or CAPOX_8
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
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.
FOLFOX_6 or CAPOX_4
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Young Suk Park
Professor
Principal Investigators
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Young Suk Park, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Seoul, Korea
Locations
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Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
School of Medicine, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Sungkyunkwan University Masan Samsung Hospital
Masan, Gyeongsangnam, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam, South Korea
Kosin Medical Center
Busan, , South Korea
Dong-A University Medical Center
Busan, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Yonsei University College of Medicine
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's hospital, Catholic Univerisity
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Chung-Ang University College of Medicine
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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2009-11-008
Identifier Type: OTHER
Identifier Source: secondary_id
2009-11-008
Identifier Type: -
Identifier Source: org_study_id
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