Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12) (CLAUDIA)

August 5, 2026 updated by: Sae-Won Han, Seoul National University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
      • Goyang, South Korea
        • Recruiting
        • National Cancer Center
        • Contact:
      • Hwasun, South Korea
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Sang Hee Cho, M.D.,Ph.D
          • Phone Number: 061-379-7114
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
          • Jin won Kim, M.D.,Ph.D
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
      • Suwon, South Korea
        • Recruiting
        • Ajou University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who willingly consented and signed the informed consent form to participate in the study
  2. Age range of 19 to 75 years
  3. Adenocarcinoma of colon confirmed by histology
  4. 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.)
  5. 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)
  6. A ctDNA test performed 3 to 6 weeks after surgery reveals a positive MRD
  7. ECOG performance scale of 0-1 (only 1 is allowed for 70-75 years old)
  8. 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)]
  9. Appropriate liver function (total bilirubin ≤1.5xULN, AST and ALT ≤3xULN)
  10. Appropriate renal function (serum creatine ≤1.5xULN, renal clearance rate ≥50 ml/min)
  11. Patients who are deemed to understand the study protocol and are willing to participate in the trial until it is completed

Exclusion Criteria:

  1. Pregnant or lactating women
  2. 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)
  3. 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
  4. 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]
  5. 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)
  6. Significant uncontrolled infections or other uncontrolled comorbidities
  7. Symptomatic inflammatory bowel disease
  8. Allogeneic transplantation history necessitating immunosuppressive therapy
  9. 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
  10. Recurrent or residual disease identified clinically or radiographically
  11. Previous history of irinotecan treatment
  12. Polyposis including familial adenomatous polyps
  13. Two or more colon or rectal cancers with a pathologic stage greater than II that were detected concurrently or within the last three years
  14. 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
  15. Prior clinical trial participation and usage of investigational drugs or devices following radical resection of colon cancer
  16. 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)
  17. Previous anaphylactic reaction or severe and unexpected reactions to fluoropyrimidines or platinum
  18. Gilbert's syndrome, dehydro-pyridine dehydrogenase (DPD) deficiency, or homozygous UGT1A1*28 alleles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mFOLFIRINOX intensified chemotherapy

6 cycles of mFOLFIRINOX

- Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks
Drug: 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
Other Names:
  • Campto
Active Comparator: FOLFOX or CAPOX adjuvant chemotherapy

FOLFOX 6 cycles or CAPOX 4 cycles

  • FOLFOX regimen: 6 cycles every 2 weeks or
  • CAPOX regimen: 4 cycles every 3 weeks
Drug: FOLFOX or CAPOX adjuvant chemotherapy

  1. 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
Other Names:
  • Campto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through completion of follow-up (estimated to be 36 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor DNA (ctDNA) clearance rate
Time Frame: The data of ctDNA clearance rate will be collected at 10 time points
The proportion of patients with circulating tumor DNA clearance after 36months study treatment.
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)
Overall survival is defined as the time from beginning of study treatment until death due to any cause.
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)
The number of patients with adverse events and the severity according to CTCAE v5.0.
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)
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.
Through completion of follow-up (estimated to be 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sae-Won Han, MD,PhD, Seoul National University Hospital
  • Principal Investigator: Jinwon Kim, MD, Seoul National University Bundang Hospital
  • Principal Investigator: Jin Soo Kim, SMG-SNU Boramae Medical Center
  • Principal Investigator: Sun Young Kim, M.D.,Ph.D, Asan Medical Center
  • Principal Investigator: Seung Hoon Beom, M.D.,Ph.D, Severance Hospital
  • Principal Investigator: In Kyu Hwang, M.D.,Ph.D, Chung-Ang University Hospital
  • Principal Investigator: Byung Wook Kang, M.D.,Ph.D, Kyungpook National University Chilgok Hospital
  • Principal Investigator: Sang Hee Cho, M.D.,Ph.D, Chonnam National University Hospital
  • Principal Investigator: Moon Ki Choi, M.D.,Ph.D, National Cancer Center
  • Principal Investigator: Seung Tae Kim, M.D.,Ph.D, Samsung Medical Center
  • Principal Investigator: Seock Yun Kang, M.D.,Ph.D, Ajou University School of Medicine
  • Principal Investigator: Seok Jae Huh, M.D.,Ph.D, Dong-A University Hospital
  • Principal Investigator: Sang Cheul Oh, M.D.,Ph.D, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2205-029-1322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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