EXtended CriteriA treatment for LIver Metastases with heavy tumour BURden

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002388-87-NO

Enrollment

Registered

2019-09-17

Start date

2020-04-27

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Patients with resectable colorectal liver metastases

Interventions

Product Name: Floxuridine Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: FLOXURIDINE CAS Number: 50-91-9 Current Sponsor code: Fresenius Kabi Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?Multiple colorectal liver metastases (8 or more metastases or 5 or more with marginal resectability) ?Progression on 1st line chemotherapy ?Primary tumour resected (for Excalibur 2 only) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19

Exclusion criteria

Exclusion criteria: ?Extrahepatic disease ?Age > 70 years (for Excalibur 1 only)

Design outcomes

Primary

Measure	Time frame
Main Objective: Overall survival;Secondary Objective: Efficacy Radiological response to HAI/FUDR;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: at 2 years after randomization	—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy Radiological response to HAI/FUDR Safety ;Timepoint(s) of evaluation of this end point: at 5- and 10- years after randomization.	—

Countries

Norway

Contacts

Public ContactSvein Dueland

Oslo University Hospital

svedue@ous-hf.no4722935789

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026