Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
- Registration Number
- NCT01092481
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1580
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOLFOX_12 or CAPOX_8 oxaliplatin 6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX FOLFOX_6 or CAPOX_4 oxaliplatin 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
- Primary Outcome Measures
Name Time Method disease-free survival 3 years
- Secondary Outcome Measures
Name Time Method safety profiles 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.
overall survival 3 years quality of life 3 years
Trial Locations
- Locations (17)
National Cancer Center
🇰🇷Goyang, Gyeonggi, Korea, Republic of
Seoul St. Mary's hospital, Catholic Univerisity
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Sungkyunkwan University Masan Samsung Hospital
🇰🇷Masan, Gyeongsangnam, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Dong-A University Medical Center
🇰🇷Busan, Korea, Republic of
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Chung-Ang University College of Medicine
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnam, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Gyeonggi, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Gyeonggi, Korea, Republic of
School of Medicine, CHA University
🇰🇷Seongnam, Gyeonggi, Korea, Republic of
Kosin Medical Center
🇰🇷Busan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of