Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05534087 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: CLAUDIA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 3 → 13 locationsv7
  2. 2 versions Re-verified since Nov 26, 2024, no change to tracked fieldsv5-v6
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v4 Show 1 more changeShow less
    • Study sites: 0 to 3
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Oct 1, 2022 to Dec 15, 2022 Enrollment target: 228 to 236 · Eligibility criteria expanded, about 7 words · Study description shortened, about 5 words · 1 morev2 Show 4 more changesShow less
    • Enrollment target: 228 to 236
    • Eligibility criteria expanded, about 7 words
    • Study description shortened, about 5 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05534087
Lead Sponsor Seoul National University Hospital
Conditions Colon Cancer
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov