Colon CancerPhase 3CLAUDIANCT05534087
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
A Phase 3 study testing mFOLFIRINOX-FOLFIRI intensified chemotherapy and FOLFOX or CAPOX adjuvant chemotherapy in people with Colon Cancer, run by Seoul National University Hospital at 13 sites in South Korea.
Trial summary
This study is a prospective, open-label, randomized phase 3 clinical trial. It aims to investigate if the early introduction of intensified chemotherapy (3 months of modified FOLFIRINOX) improves the 3-year disease-free survival rate compared to standard treatment (FOLFOX/CAPOX for an additional three months to… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- mFOLFIRINOX-FOLFIRI intensified chemotherapy and FOLFOX or CAPOX adjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 15 Dec 2022to 30 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who willingly consented and signed the informed consent form to participate in the study
- Age range of 19 to 75 years
- Adenocarcinoma of colon confirmed by histology
- Patients with stage II-III colon cancer as defined by the American Joint Committee on Cancer's eighth edition (Stage II cancer is limited to patients who are at a high risk, with more than one risk factor for recurrence.)
- Patients who have completed the sixth cycle of FOLFOX or the fourth cycle of CAPOX adjuvant chemotherapy for colon cancer following radical resection (R0 resection)
- A ctDNA test performed 3 to 6 weeks after surgery reveals a positive MRD
Show all 11Show fewer
- ECOG performance scale of 0-1 (only 1 is allowed for 70-75 years old)
- Adequate bone marrow function [ANC ≥1,300/LL, platelets ≥75,000/LL, hemoglobin ≥8.0g/dL (may be eligible in study if intermittent transfusion is required)]
- Appropriate liver function (total bilirubin ≤1.5xULN, AST and ALT ≤3xULN)
- Appropriate renal function (serum creatine ≤1.5xULN, renal clearance rate ≥50 ml/min)
- Patients who are deemed to understand the study protocol and are willing to participate in the trial until it is completed
Who cannot join
- Pregnant or lactating women
- Pregnant women who had a positive pregnancy test at the time of the baseline examination (postmenopausal women must be amenable for at least 12 months to be considered non-fertility)
- Sexually active men and women of reproductive age who are unwilling to use contraception throughout the study treatment and for a period of 6 months (female) or 3 months (male) following the discontinuation of study treatment
- Clinically significant heart condition [unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure, or significant heart arrhythmia above NYHA II, or acute coronary syndrome, including myocardial infarction within the last 6 months]
- Active viral infections such as HIV (However, HBV carriers may enroll if their HBV DNA titer is less than 20,000 IU/ml, and antiviral drugs for hepatitis B may be administered prophylactically at the investigator's discretion)
- Significant uncontrolled infections or other uncontrolled comorbidities
Show all 18Show fewer
- Symptomatic inflammatory bowel disease
- Allogeneic transplantation history necessitating immunosuppressive therapy
- A history of other malignancies identified within the last three years, except for completed removed basal cell carcinoma of the skin, completely removed cervical epithelial carcinoma, and thyroid cancer that has been treated, including surgery
- Recurrent or residual disease identified clinically or radiographically
- Previous history of irinotecan treatment
- Polyposis including familial adenomatous polyps
- Two or more colon or rectal cancers with a pathologic stage greater than II that were detected concurrently or within the last three years
- When the investigator determines that the subjects' safety may be jeopardized during the study because of other serious or unstable pre-existing medical or mental conditions
- Prior clinical trial participation and usage of investigational drugs or devices following radical resection of colon cancer
- Patients with peripheral neuropathy who have a CTCAE v5 grade 3 or higher functional disability (corresponds to "severe symptoms, limiting self-care activity of daily living" according to CTCAE v5 criteria)
- Previous anaphylactic reaction or severe and unexpected reactions to fluoropyrimidines or platinum
- Gilbert's syndrome, dehydro-pyridine dehydrogenase (DPD) deficiency, or homozygous UGT1A1*28 alleles
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Recruiting
Dong-A University Hospital
Busan
Seock Jae Huh, M.D.,Ph.D, 051-240-2000, doctorsj@naver.com
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Byung Wook Kang, M.D.,Ph.D, 053-200-2114, bwkang@knu.ac.kr
- Recruiting
National Cancer Center
Goyang
Moon Ki Choi, M.D.,Ph.D, 031-920-0114, choi.moonki@nc.re.kr
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun
Sang Hee Cho, M.D.,Ph.D, 061-379-7114
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Jin Won Kim, M.D.,Ph.D, 1588-3369, kimjw@snu.ac.kr
- Recruiting
Asan Medical Center
Seoul
Sun Young Kim, M.D.,Ph.D, 1688-7575, sunyoungkim@amc.seoul.kr
- Recruiting
Chung-Ang University Hospital
Seoul
In Kyu Hwang, M.D.,Ph.D, 1800-1114, oncology@cau.ac.kr
- Recruiting
Korea University Guro Hospital
Seoul
Sang Cheul Oh, M.D.,Ph.D, 02-2626-1114, sachoh@korea.ac.kr
- Recruiting
Samsung Medical Center
Seoul
Seung Tae Kim, M.D.,Ph.D, 1599-3114, seungtae1.kim@samsung.com
- Recruiting
Seoul National University Hospital
Seoul
Sae-Won Han, M.D.,Ph.D, 02-6072-5220, saewonhan1@snu.ac.kr
Jin won Kim, M.D.,Ph.D
- Recruiting
Severance Hospital
Seoul
Seung Hoon Beom, M.D.,Ph.D, 02-2228-0114, beomsh@yuhs.ac.kr
- Recruiting
SMG-SNU Boramae Medical Center
Seoul
Jin Soo Kim, M.D.,Ph.D, 02-870-2114, gistmd@gmail.com
- Recruiting
Ajou University Hospital
Suwon
Seock Yun Kang, M.D.,Ph.D, 1688-6114, kangsy01@ajou.ac.kr
About this study
Official title: A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
This study is a prospective, open-label, randomized phase 3 clinical trial. It aims to investigate if the early introduction of intensified chemotherapy (3 months of modified FOLFIRINOX) improves the 3-year disease-free survival rate compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy
Read the detailed description
About 25% of resectable high-risk stage 2 or stage 3 colon cancers are known to relapse despite standard treatments, including radical resection and adjuvant chemotherapy.
Using circulating tumor DNA (ctDNA)-based minimal residual cancer (MRD) detection technology, patients whose MRD is not eradicated after adjuvant chemotherapy could be identified. Early introduction of intensified chemotherapy for this group of patients could prolong survival time and increase cure rates.
This study is part of the Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (CLADIA Colon Cancer). Part 1 of the platform study (Prospective Observational Study of ctDNA Monitoring During Adjuvant) is a large-scale, prospective observational study that follows ctDNA up to three years after resection in about 1,200 patients with stage 2-3 colon cancer.
This study (Part 2) aims to study the efficacy of early intensified chemotherapy (3 months of modified FOLFIRINOX ) compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy.
- Conditions
- Colon Cancer
- Being tested
- mFOLFIRINOX-FOLFIRI intensified chemotherapy, FOLFOX or CAPOX adjuvant chemotherapy
- Keywords
- Minimal residual disease, Intensified chemotherapy
- Medical subject headings
- Colonic Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOX-FOLFIRI intensified chemotherapyDrug
(1) Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks
- Oxaliplatin 85mg/m2 IV infusion over 120 min D1
- Leucovorin 400mg/m2 IV (concurrently with oxaliplatin)
- Irinotecan 150mg/m2 IV infusion over 60-90 min D1
- 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2
FOLFOX or CAPOX adjuvant chemotherapyDrug
- FOLFOX regimen: 6 cycles every 2 weeks
- Oxaliplatin 85mg/m2 IV infusion over 120 min D1
- Leucovorin 400mg/m2 IV infusion over 120 min (concurrently with oxaliplatin)
- 5-fluorouracil 400mg/m2 IV bolus D1
- 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2 or
- CAPOX regimen: 4 cycles every 3 weeks
- Oxaliplatin 130mg/m2 IV infusion over 120 min D1
- Capecitabine 1,000mg/m2 PO bid D1-14
| Study group | Role | What they receive |
|---|---|---|
| mFOLFIRINOX intensified chemotherapy | Experimental | 6 cycles of mFOLFIRINOX
- Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks Receives: Drug: mFOLFIRINOX-FOLFIRI intensified chemotherapy |
| FOLFOX or CAPOX adjuvant chemotherapy | Active comparator | FOLFOX 6 cycles or CAPOX 4 cycles
* FOLFOX regimen: 6 cycles every 2 weeks or
* CAPOX regimen: 4 cycles every 3 weeks Receives: Drug: FOLFOX or CAPOX adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization
Measured: Through completion of follow-up (estimated to be 36 months)
Secondary outcomes (4)
Circulating tumor DNA (ctDNA) clearance rate
The proportion of patients with circulating tumor DNA clearance after 36months study treatment.
Measured: The data of ctDNA clearance rate will be collected at 10 time points
5-year overall survival rate (5y-OS rate)
Overall survival is defined as the time from beginning of study treatment until death due to any cause.
Measured: Through completion of follow-up (estimated to be 60 months)
Treatment-Related Adverse Events
The number of patients with adverse events and the severity according to CTCAE v5.0.
Measured: Through completion of follow-up (estimated to be 36 months)
EORTC QLQ-C30 scale
Using the EORTC QLQ-C30 scale (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30) to evaluate the quality of life of patients.
Measured: Through completion of follow-up (estimated to be 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Dec 2022
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sae-Won Han, Seoul National University Hospital
- Investigators
- Sae-Won Han, MD,PhD, Principal investigator, Seoul National University HospitalJinwon Kim, MD, Principal investigator, Seoul National University Bundang HospitalJin Soo Kim, Principal investigator, SMG-SNU Boramae Medical CenterSun Young Kim, M.D.,Ph.D, Principal investigator, Asan Medical CenterSeung Hoon Beom, M.D.,Ph.D, Principal investigator, Severance HospitalIn Kyu Hwang, M.D.,Ph.D, Principal investigator, Chung-Ang University HospitalByung Wook Kang, M.D.,Ph.D, Principal investigator, Kyungpook National University Chilgok HospitalSang Hee Cho, M.D.,Ph.D, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534087
- Sponsor's protocol ID
- H-2205-029-1322
- Acronym
- CLAUDIA
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05534087
- Acronym / sponsor ID
- CLAUDIA / H-2205-029-1322
- Conditions
- Colon Cancer
- Keywords
- Minimal residual disease, Intensified chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 9 Sep 2022 (actual)
- 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 a prospective, open-label, randomized phase 3 clinical trial. It aims to investigate if the early introduction of intensified chemotherapy (3 months of modified FOLFIRINOX) improves the 3-year disease-free survival rate compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy
Detailed description
About 25% of resectable high-risk stage 2 or stage 3 colon cancers are known to relapse despite standard treatments, including radical resection and adjuvant chemotherapy.
Using circulating tumor DNA (ctDNA)-based minimal residual cancer (MRD) detection technology, patients whose MRD is not eradicated after adjuvant chemotherapy could be identified. Early introduction of intensified chemotherapy for this group of patients could prolong survival time and increase cure rates.
This study is part of the Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (CLADIA Colon Cancer). Part 1 of the platform study (Prospective Observational Study of ctDNA Monitoring During Adjuvant) is a large-scale, prospective observational study that follows ctDNA up to three years after resection in about 1,200 patients with stage 2-3 colon cancer.
This study (Part 2) aims to study the efficacy of early intensified chemotherapy (3 months of modified FOLFIRINOX ) compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFIRINOX intensified chemotherapy | Experimental | Drug: mFOLFIRINOX-FOLFIRI intensified chemotherapy6 cycles of mFOLFIRINOX - Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks |
| FOLFOX or CAPOX adjuvant chemotherapy | Active comparator | Drug: FOLFOX or CAPOX adjuvant chemotherapyFOLFOX 6 cycles or CAPOX 4 cycles * FOLFOX regimen: 6 cycles every 2 weeks or * CAPOX regimen: 4 cycles every 3 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who willingly consented and signed the informed consent form to participate in the study
- Age range of 19 to 75 years
- Adenocarcinoma of colon confirmed by histology
- Patients with stage II-III colon cancer as defined by the American Joint Committee on Cancer's eighth edition (Stage II cancer is limited to patients who are at a high risk, with more than one risk factor for recurrence.)
- Patients who have completed the sixth cycle of FOLFOX or the fourth cycle of CAPOX adjuvant chemotherapy for colon cancer following radical resection (R0 resection)
Key exclusion criteria (18 listed)
- Pregnant or lactating women
- Pregnant women who had a positive pregnancy test at the time of the baseline examination (postmenopausal women must be amenable for at least 12 months to be considered non-fertility)
- Sexually active men and women of reproductive age who are unwilling to use contraception throughout the study treatment and for a period of 6 months (female) or 3 months (male) following the discontinuation of study treatment
- Clinically significant heart condition [unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure, or significant heart arrhythmia above NYHA II, or acute coronary syndrome, including myocardial infarction within the last 6 months]
- Active viral infections such as HIV (However, HBV carriers may enroll if their HBV DNA titer is less than 20,000 IU/ml, and antiviral drugs for hepatitis B may be administered prophylactically at the investigator's discretion)
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 |
|---|---|---|
| mFOLFIRINOX-FOLFIRI intensified chemotherapy(1) Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks * Oxaliplatin 85mg/m2 IV infusion over 120 min D1 * Leucovorin 400mg/m2 IV (concurrently with oxaliplatin) * Irinotecan 150mg/m2 IV infusion over 60-90 min D1 * 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2 | Drug | mFOLFIRINOX intensified chemotherapy |
| FOLFOX or CAPOX adjuvant chemotherapy1. FOLFOX regimen: 6 cycles every 2 weeks * Oxaliplatin 85mg/m2 IV infusion over 120 min D1 * Leucovorin 400mg/m2 IV infusion over 120 min (concurrently with oxaliplatin) * 5-fluorouracil 400mg/m2 IV bolus D1 * 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2 or 2. CAPOX regimen: 4 cycles every 3 weeks * Oxaliplatin 130mg/m2 IV infusion over 120 min D1 * Capecitabine 1,000mg/m2 PO bid D1-14 | Drug | FOLFOX or CAPOX adjuvant chemotherapy |
Primary outcome
3-year disease-free survival rate
Time frame: Through completion of follow-up (estimated to be 36 months)
The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization
4 secondary outcomes
Circulating tumor DNA (ctDNA) clearance rate
Time frame: The data of ctDNA clearance rate will be collected at 10 time points
5-year overall survival rate (5y-OS rate)
Time frame: Through completion of follow-up (estimated to be 60 months)
Treatment-Related Adverse Events
Time frame: Through completion of follow-up (estimated to be 36 months)
EORTC QLQ-C30 scale
Time frame: Through completion of follow-up (estimated to be 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Colon Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
Collection of Blood From Patients With Cancer
Prostate Cancer, Breast Cancer
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
RecruitingObservational study
Genomic Services Research Program
Colon Cancer, Breast Cancer
Not yet recruitingPhase 2
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
Colon 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.
Sae-Won Han, MD,PhD principal investigator
Seoul National University Hospital
Jinwon Kim, MD principal investigator
Seoul National University Bundang Hospital
Jin Soo Kim principal investigator
SMG-SNU Boramae Medical Center
13 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 mFOLFIRINOX-FOLFIRI intensified chemotherapy and FOLFOX or CAPOX adjuvant chemotherapy in people with Colon Cancer, run by Seoul National University Hospital at 13 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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sae-Won Han, MD,PhD (82-2-2072-0795, saewon1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (time frame: Through completion of follow-up (estimated to be 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.