Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
1 other identifier
interventional
1,580
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2010
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2009
CompletedStudy Start
First participant enrolled
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 21, 2019
May 1, 2019
9.9 years
November 22, 2009
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival
3 years
Secondary Outcomes (3)
overall survival
3 years
quality of life
3 years
safety profiles
3 years
Study Arms (2)
FOLFOX_12 or CAPOX_8
ACTIVE COMPARATOR6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
FOLFOX_6 or CAPOX_4
EXPERIMENTAL3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 431-070, South Korea
Soon Chun Hyang University Hospital Bucheon
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
Related Publications (1)
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.
PMID: 35772045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Suk Park, M.D.,Ph.D.
Samsung Medical Center, Seoul, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 22, 2009
First Posted
March 25, 2010
Study Start
January 26, 2010
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
May 21, 2019
Record last verified: 2019-05