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

ABSTRACT: 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 Radioembolization, one month after the RFA procedure. The RFA procedure can be performed percutaneously, laparoscopically or during an open procedure. The duration of the RFA procedure depends on the surgical approach and the number of the lesions. One or two weeks prior to the radioembolization procedure, each patient will undergo pre-procedural screening by means of hepatic angiography and subsequently technetium-99m-labelled albumin macroaggregates (99mTc-MAA) injection, followed by planar imaging and Single Photon Emission Computed Tomography (SPECT). The pre-procedural angiography permits visualization of the anatomy of the vessels and provides an opportunity to embolize arteries if necessary (to spare the gastric and duodenal arterial flow from incorporating radioactive spheres). The 99mTc-MAA and the subsequent nuclear imaging will determine the presence of any shunts from the hepatic arterial system to the pulmonary or gastrointestinal venous systems. Both the pre-procedural screening and the radioembolization procedure will take about 2 tot 3 hours depending on the hepatic vascular anatomy. Patients will be admitted the day before the procedure and discharged the day after the procedure. The main study parameter is the local liver recurrence rate after RFA combined with Yttrium-90 radioembolization for patients with CRLM. This will be assessed by the number and percentage of patients with local liver recurrence, 12 months after the RFA procedure. Local liver recurrence is defined as: radiologic detection of residual or recurrent viable tumor which is related to the ablation Primary outcome(s): 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) Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Crossover

DISEASE(S): Colorectal Liver Metastases, Recurrence, Radiofrequency Ablation, Radioembolization

PROVIDER: 18242 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR