Actively Recruiting
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
Led by Seoul National University Hospital · Updated on 2024-11-29
236
Participants Needed
3
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- ECOG performance scale of 0-1 (only 1 is allowed for 70-75 years old)
- Adequate bone marrow function [ANC 651,300/LL, platelets 6575,000/LL, hemoglobin 658.0g/dL (may be eligible in study if intermittent transfusion is required)]
- Appropriate liver function (total bilirubin 651.5xULN, AST and ALT 653xULN)
- Appropriate renal function (serum creatine 651.5xULN, renal clearance rate 6550 ml/min)
- Patients who are deemed to understand the study protocol and are willing to participate in the trial until it is completed
You will not qualify if you...
- 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
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
National Cancer Center
Goyang, South Korea
Actively Recruiting
2
Jin Won Kim
Seongnam, South Korea
Actively Recruiting
3
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Sae-Won Han, MD,PhD
CONTACT
Y
Youngjun Cha, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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