drugset
drugset / Trial / NCT05062889

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

NCT05062889 ↗

Phase 2 Suspended 477 enrolled Gruppo Oncologico del Nord-Ovest Foundation Medicine · collabSeagen Inc. · collabServier · collab
RandomizedSequentialOpen-labelTreatment

Summary

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX

Timeline

Start
2023-05-17
Primary completion
2027-10
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Subject Irinotecan Small molecule 165 mg/m2 Intravenous
Subject Levoleucovorin Unknown 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Trifluridine/Tipiracil Unknown 35 mg/m2 Oral
Subject Tucatinib Small molecule 300 mg Oral
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Subject fluorouracil Small molecule 3200 mg/m2 Intravenous

Indications

malignant colon neoplasm