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

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

Trial Details

NCT ID
NCT05534087
Phase
PHASE3
Sponsor
Seoul National University Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • mFOLFIRINOX-FOLFIRI intensified chemotherapy
  • FOLFOX or CAPOX adjuvant chemotherapy
Locations (sample)
  • Busan, South Korea|35.10168,129.03004
  • Daegu, South Korea|35.87028,128.59111
  • Goyang, South Korea|36.21689,127.19731
  • Hwasun, South Korea|35.06125,126.98746
  • Seongnam, South Korea|35.48474,129.30505

Key Eligibility Criteria

  • 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 patien…

For full eligibility, visit ClinicalTrials.gov.

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