Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients
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
Outcome
Outcome not reported
Stopped (Enrollment): “due to earlier termination of the agreement between the Sponsor and Central Laboratory for screening test. Enrollment will reopen as soon as a new laboratory is identified.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Subject | L-LEUCOVORIN | 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 |