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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Medical Center
  • Soon Chun Hyang University Hospital Bucheon
  • National Cancer Center
  • School of Medicine, CHA University
  • Sungkyunkwan University Masan Samsung Hospital
  • Pusan National University Yangsan Hospital
  • Chonnam National University Hwasun Hospital
  • Kosin Medical Center
  • Dong-A University Medical Center
  • Gachon University Gil Hospital
  • Yonsei University College of Medicine
  • Samsung Medical Center
  • Seoul St. Mary's hospital, Catholic Univerisity
  • Asan Medical Center
  • Soonchunhyang University Hospital
  • SMG-SNU Boramae Medical Center
  • Chung-Ang University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FOLFOX_12 or CAPOX_8

FOLFOX_6 or CAPOX_4

Arm Description

6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX

3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival
quality of life
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.

Full Information

First Posted
November 22, 2009
Last Updated
May 17, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01092481
Brief Title
Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2010 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFOX_12 or CAPOX_8
Arm Type
Active Comparator
Arm Description
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Arm Title
FOLFOX_6 or CAPOX_4
Arm Type
Experimental
Arm Description
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
oxaliplatin (modified FOLFOX-6 OR CAPOX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Title
quality of life
Time Frame
3 years
Title
safety profiles
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Suk Park, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
State/Province
Gyeonggi
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-768
Country
Korea, Republic of
Facility Name
School of Medicine, CHA University
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Sungkyunkwan University Masan Samsung Hospital
City
Masan
State/Province
Gyeongsangnam
ZIP/Postal Code
630-522
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Kosin Medical Center
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul St. Mary's hospital, Catholic Univerisity
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Seoul
ZIP/Postal Code
140-210
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Chung-Ang University College of Medicine
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35772045
Citation
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.
Results Reference
derived

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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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