Skip to content

CROSSROADS 1

De-escalation of treatment in early-stage colon cancer: omitting completion surgery in patients with locally excised pT1-T2 colon cancer. A national prospective health care evaluation. CROSSROADS 1. - De-Escalation of treatment in pT1-T2 locally resected colon cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57946
Enrollment
588
Registered
2025-07-01
Start date
2025-09-02
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

Active follow-up, with completion surgery if necessary.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (= 18 years) with 5-15% 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 1 histological risk factor R0 resected pedunculated pT1 colon cancer with 1 or more histological risk factors R0 resected pT2 colon cancer without any histological risk factors R1/Rx resected pT1 colon cancer without histological risk factors and without evidence of residual cancer in additional scar excision 2. Charlson Comorbidity Index = 8 Histological risk factors include: lymphovascular invasion, high grade tumour budding (Bd2-3) and poor 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

MeasureTime frame
5-year cancer specific survival

Secondary

MeasureTime frame
3-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

crossroads@umcutrecht.nl+31887560886

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)