KCT0007644
Recruiting
未知
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (CLAUDIA Colon Cancer, KCSG CO22-12) Part 2: A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients with Positive MRD after Curative Resection
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Hospital
- Enrollment
- 236
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 three 3 to 6 weeks following 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)
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
Outcomes
Primary Outcomes
Not specified
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