OPTIMISE OPTIMIzation of treatment SElection and follow up in oligometastatic colorectal cancer – a ctDNA guided phase II randomized approach

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509814-12-00

Acronym

KFE-2022

Enrollment

381

Registered

2023-12-11

Start date

2021-09-22

Completion date

Unknown

Last updated

2026-01-20

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

Conditions

Colorectal cancer with metastasis

Brief summary

Rate of patients free from recurrent colorectal cancer at 2 years after inclusion

Detailed description

Rate of CTCAE grade 3-5 toxicity 6 months post-treatment, Molecular biological response to therapy after 6 months, Molecular biological disease-free survival at 1 year, Time to molecular biological recurrence, Time to radiological recurrence, Local and distant relapse, Overall survival, QoL (EQ-5D-5L, EORTC QLQ–C30 and –CR29, explorative ctDNA utility questionnaire), Cost-effective analysis

Interventions

DRUGTEGAFUR

DRUGCOMBINATIONS

DRUGCALCIUM FOLINATE

DRUGIRINOTECAN

DRUGOXALIPLATIN

DRUGCAPECITABINE

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of patients free from recurrent colorectal cancer at 2 years after inclusion	—

Secondary

Measure	Time frame
Rate of CTCAE grade 3-5 toxicity 6 months post-treatment, Molecular biological response to therapy after 6 months, Molecular biological disease-free survival at 1 year, Time to molecular biological recurrence, Time to radiological recurrence, Local and distant relapse, Overall survival, QoL (EQ-5D-5L, EORTC QLQ–C30 and –CR29, explorative ctDNA utility questionnaire), Cost-effective analysis	—

Countries

Denmark, Germany, Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026