Intensified chemotherapy for colon cancer based on ctDNA results

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial investigates whether early intensified chemotherapy using modified FOLFIRINOX can improve disease-free survival rates in patients with stage 2-3 colon cancer who have detectable minimal residual disease (MRD) after standard adjuvant chemotherapy. The study is part of a larger platform that monitors circulating tumor DNA (ctDNA) to identify patients at high risk of relapse. Participants will be randomized to receive either the intensified chemotherapy or continue with standard treatment. The goal is to determine if the intensified approach can lead to better long-term outcomes for these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Dong-A University Hospital
  Busan, South Korea Recruiting
• Kyungpook National University Chilgok Hospital
  Daegu, South Korea Recruiting
• National Cancer Center
  Goyang, South Korea Recruiting
• Chonnam National University Hwasun Hospital
  Hwasun, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam, South Korea Recruiting
• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Sae-Won Han, MD,PhD — Seoul National University Hospital
• Study coordinator: Sae-Won Han, MD,PhD
• Email: saewon1@snu.ac.kr
• Phone: 82-2-2072-0795

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LTZ-232: a first-in-human test in advanced colorectal and other solid tumors

  A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.

  Recruiting Phase 1 LTZ Therapeutics, Inc. · Scottsdale, Arizona · NCT07878988

• ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer

  This study tests whether tracking ctDNA can guide neoadjuvant immunotherapy and surgical decisions for people with dMMR/MSI-H colon cancer, using PD-1 inhibitors first and adding CTLA-4 inhibitors if ctDNA remains detectable.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07841236

• Tafolecimab with chemoimmunotherapy as neoadjuvant treatment for locally advanced colon cancer

  This study tests whether adding tafolecimab to a chemoimmunotherapy regimen helps shrink locally advanced colon cancer before surgery in adults who have pMMR/MSS tumors.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT07840677

• Neoadjuvant pembrolizumab and porustobart for resectable MSS colon cancer

  This trial tests whether giving pembrolizumab with porustobart before surgery can shrink MSS colon cancer and improve outcomes, comparing one versus two doses of porustobart.

  Recruiting at 3 sites Phase 2 Solstice Oncology, Inc. · Los Angeles, California and 29 other locations · NCT07808151

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• SHY-ONC6: a new anti-cancer drug tested in adults with advanced solid tumors

  This early-phase study tests SHY-ONC6 to see if it is safe and can help people with advanced solid tumors after standard therapies have failed.

  Recruiting at 3 sites Phase 1 SHY Therapeutics · Scottsdale, Arizona and 2 other locations · NCT07705334

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.