Colon cancer
Conditions
Interventions
Active follow-up or completion surgery
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (= 18 years) with 15-25% risk of lymph node metastasis after local excision of pT1-2 colon carcinoma, in accordance with Table 5.2.2 of the Dutch Colorectal Cancer Guideline:R0 resected non-pedunculated pT1 colon cancer with only 2 risk factorsR1/Rx resected non-pedunculated pT1 colon cancer with 1 histological risk factor and without evidence of residual cancer in additional scar excisionR0 resected pT2 colon cancer with 1 risk factor2. Charlson Comorbidity Index = 8 Histological risk factors include: lymphovascular invasion, high grade tumor budding (Bd2-3),high grade differentiation
Exclusion criteria
Exclusion criteria: Non-adenocarcinomaNeo-adjuvant treatmentSuspicion of distant metastasis at baseline imagingHereditary colorectal cancer or inflammatory bowel disease (IBD)A suspected lymph node at baseline imaging with a short-axis size > 10 mmSynchronous secondary colon cancerPrevious colon cancer within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year cancer specific survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year cancer specific survival3-year and 5-year overall survival 3-year and 5-year disease free survival Adherence to the guidelineCumulative proportion of distant metastasisCumulative proportion of locoregional recurrencesProportion of salvageable recurrencesCost-effectiveness (costs per treatment strategy, QALY)Quality of life | — |
Countries
Netherlands
Contacts
Public ContactL.M.G. Moons
Universitair Medisch Centrum Utrecht
Outcome results
None listed