Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

Phase III multicentric, open-label, randomized study The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma

Trial Details

NCT ID
NCT06197425
Phase
PHASE3
Sponsor
Centre Hospitalier Universitaire Dijon
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • "FOLFIRI" cures
  • Trifluridine cures
  • BIOLOGICAL ASSESSMENT
  • Questionnaires
  • Thoracic-abdomino-pelvic scan or MRI
Locations (sample)
  • Dijon, France|47.31344,5.01391

Key Eligibility Criteria

  • Fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma previously treated by standard adjuvant chemotherapy or peri-op…
  • Positive ctDNA screening (methylation) and confirmation (NGS) on samples collected at the 3- or 6 months follow-up visit post-adjuvant chemotherapy
  • Patients ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is \>14 for patients 70 years or older)
  • Subjects with WHO performance status \< 2

For full eligibility, visit ClinicalTrials.gov.

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