Colon carcinoma large bowel cancer Bowel cancer
Conditions
Interventions
Patients will be asked informed consent to immediately analyse their
post-surgery sample for ctDNA. Patients with detectable ctDNA are seen as high
risk and will be offered adjuvant chemotherapy.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Informed consent for PLCRC with specific consent for additional blood withdrawals, collection of tissue and being informed about future experimental research - Histological confirmed stage II colon cancer - Fit for combination chemotherapy (fluoropyrimidin and oxaliplatin) according to the treating physician
Exclusion criteria
Exclusion criteria: - Indication for adjuvant chemotherapy according to treating physician - Another malignancy in previous 5 years, except carcinoma in situ or skin cancer other than melanoma - Incomplete tumor resection (R1 or R2 resection) - Contra-indications for fluoropyrimidines or oxaliplatin - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with detectable ctDNA in their blood starting with chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recurrence Rate 2 years after surgery (intention-to-treat analysis) - 2-year RR in a per-protocol analysis - 5-year RR (intention-to-treat and per-protocol) - 2- and 5-year disease free survival (DFS) rate - disease-related 5- and 7-year overall survival (OS) rate - quality of life (QoL), RR in patients without detectable ctDNA after surgery - time-to-recurrence (TTR) -cost-effectiveness of the ctDNA-based treatment. | — |
Countries
Netherlands
Contacts
Public ContactM. Koopman
Universitair Medisch Centrum Utrecht
Outcome results
None listed