Colon CancerPhase 3NCT01092481
Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
A Phase 3 study testing oxaliplatin in people with Colon Cancer, run by Samsung Medical Center at 17 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,580 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 26 Jan 2010to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 431-070
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 420-767
Kosin Medical Center
Busan, 602-702
Dong-A University Medical Center
Busan, 602-715
National Cancer Center
Goyang-si, Gyeonggi-do, 410-768
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam, 519-809
Gachon University Gil Hospital
Incheon, 405-760
Sungkyunkwan University Masan Samsung Hospital
Masan, Gyeongsangnam, 630-522
School of Medicine, CHA University
Seongnam-si, Gyeonggi-do, 463-712
Yonsei University College of Medicine
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Seoul St. Mary's hospital, Catholic Univerisity
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Soonchunhyang University Hospital
Seoul, 140-210
SMG-SNU Boramae Medical Center
Seoul, 156-707
Chung-Ang University College of Medicine
Seoul, 156-755
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, 626-770
About this study
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
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- oxaliplatin
- Keywords
- Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called oxaliplatin (modified FOLFOX-6 OR CAPOX)
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.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX_12 or CAPOX_8 | Active comparator | 6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX Receives: Drug: oxaliplatin |
| FOLFOX_6 or CAPOX_4 | Experimental | 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX Receives: Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: 3 years
Secondary outcomes (3)
overall survival
Measured: 3 years
quality of life
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study start26 Jan 2010
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Suk Park, Samsung Medical Center
- Investigators
- Young Suk Park, M.D.,Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092481
- Sponsor's protocol ID
- 2009-11-008
- Other IDs
- 2009-11-008
- Status last verified
- May 2019
- First submitted
- 22 Nov 2009
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35772045
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01092481
- Acronym / sponsor ID
- 2009-11-008
- Conditions
- Colon Cancer
- Keywords
- Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,580 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 Jan 2010 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX_12 or CAPOX_8 | Active comparator | Drug: oxaliplatin6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX |
| FOLFOX_6 or CAPOX_4 | Experimental | Drug: oxaliplatin3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Colon cancer other than adenocarcinoma
- Rectal cancer
- R1 or R2 resections
- Other malignancies within the last 5 years
- Symptomatic peripheral sensory neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatinAlso: oxaliplatin (modified FOLFOX-6 OR CAPOX)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. | Drug | FOLFOX_12 or CAPOX_8, FOLFOX_6 or CAPOX_4 |
Primary outcome
disease-free survival
Time frame: 3 years
3 secondary outcomes
overall survival
Time frame: 3 years
quality of life
Time frame: 3 years
safety profiles
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 35772045Kim 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.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Suk Park, M.D.,Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxaliplatin in people with Colon Cancer, run by Samsung Medical Center at 17 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.