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Combination of locally administered radiotherapy and thermal tumour destruction for treatment of liver metastases originated from primary bowel cancer

Radioembolization for Colorectal Liver Metastases after Ablation: a Prospective study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29581
Enrollment
50
Registered
2013-05-31
Start date
2013-09-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Colorectal liver metastases, Recurrence, Radiofrequency ablation, Radioembolization

Interventions

The standard treatment is Radiofrequency Ablation (RFA) for colorectal liver metastases (CRLM). Patients will not be randomized. All patients will additionally be treated with Yttirum-90 Radioemboliza

Sponsors

Prof. Dr. R. van Hillegersberg University Medical Center Utrecht Department of Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who have signed written informed consent; 2.Patients undergoing open, laparoscopic or percutaneous RFA treatment; 3.Aged 18 years or older; 4.ECOG performance status of 0-2; 5.Subjects with at least one and a maximum of five measurable lesion according to the RECIST criteria (5.0 cm or smaller in axial plane) on pre-operative imaging; 6.Normal renal and liver function tests at baseline (as described above).

Exclusion criteria

Exclusion criteria: 1.Irresectable extrahepatic metastases; 2.Liver resection; 3.Pregnant or breast-feeding patients; 4.Any form of chemotherapy within 2 months prior to the Y-90 radioembolization; 5.Exclusion criteria of radioembolization: - Compromised main portal vein; - Uncorrectable extrahepatic shunting to the gastrointestinal tract; - Unacceptable shunting to the lungs.

Design outcomes

Primary

MeasureTime frame
Local Liver Recurrence Rate (defined as radiologic detection of residual or recurrent viable tumor which is related to the ablation zone, located in the same segment as the treated lesion)

Secondary

MeasureTime frame
Treatment related adverse events Intrahepatic recurrences

Contacts

Public ContactM. Samim

University Medical Center Utrecht Department of Surgery Heidelberglaan 100

M.Samim-3@umcutrecht.nl+31-644250665

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)