Clinical trial NCT01092481: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Adjuvant FOLFOX or CAPOX Therapy
Stage II/III Colon Cancer
Adjuvant Therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 1580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: quality of life
timeFrame: 3 years
measure: safety profiles
timeFrame: 3 years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gyeonggi
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggi
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: School of Medicine, CHA University
state: Gyeonggi
city: Masan
country: Korea, Republic of
facility: Sungkyunkwan University Masan Samsung Hospital
state: Gyeongsangnam
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam
city: Busan
country: Korea, Republic of
facility: Kosin Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital, Catholic Univerisity
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University College of Medicine
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Young Suk Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.