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Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

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ClinicalTrials.gov Identifier: NCT01092481
Recruitment Status : Unknown
Verified May 2019 by Young Suk Park, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE November 22, 2009
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE January 26, 2010
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)		 disease-free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • overall survival [ Time Frame: 3 years ]
  • quality of life [ Time Frame: 3 years ]
  • safety profiles [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE 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.
Other Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)
Study Arms  ICMJE
  • Active Comparator: FOLFOX_12 or CAPOX_8
    6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
    Intervention: Drug: oxaliplatin
  • Experimental: FOLFOX_6 or CAPOX_4
    3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
    Intervention: Drug: oxaliplatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 17, 2019)		 1580
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2010)		 2660
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01092481
Other Study ID Numbers  ICMJE 2009-11-008
2009-11-008 ( Other Identifier: Samsung Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Young Suk Park, Samsung Medical Center
Original Responsible Party Young Suk Park, M.D.,Ph.D. Professor, Samsung Medical Center
Current Study Sponsor  ICMJE Samsung Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
PRS Account Samsung Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP