NCT05534087 Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
| NCT ID | NCT05534087 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Seoul National University Hospital |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 236 participants in total. It began in 2022-12-15 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Eligibility Criteria
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
Contact & Investigator
Sae-Won Han, MD,PhD
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05534087 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 75 Years, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05534087 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 236 participants.
Is NCT05534087 currently recruiting?
Yes, NCT05534087 is actively recruiting participants. Contact the research team at saewon1@snu.ac.kr for enrollment information.
Where is the NCT05534087 trial being conducted?
This trial is being conducted at Busan, South Korea, Daegu, South Korea, Goyang, South Korea, Hwasun, South Korea and 9 additional locations.
Who is sponsoring the NCT05534087 clinical trial?
NCT05534087 is sponsored by Seoul National University Hospital. The principal investigator is Sae-Won Han, MD,PhD at Seoul National University Hospital. The trial plans to enroll 236 participants.
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