Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Metastasis Colon Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
Overview
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.
Detailed description
In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.
SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.
The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.
The investigators expect to include up to 30 patients.
This is a purely observational translational study. Results will be analysed in relation to outcome data.
The study is conducted in collaboration with:
Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital
Primary outcome measures
- Feasibility and translational analysis [Time frame: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.]
Secondary outcome measures (3)
- Response Rate [Time frame: 6 months]
- Progression Free Survival [Time frame: 3 years]
- Overall Survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
- Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The Liver metastasis are not eligible for resection, RFA or SBRT
- All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
- All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
- Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Age 18 years or older
- Able to understand written information
- Consent to samples for translational research
Exclusion criteria
- Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
- Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
- Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
- Lung shunt greater than 20% or > 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
- Pregnancy
- Symptomatic lung disease precluding SIRT at interventionist´s decision
- Active uncontrolled infection
- Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (>34 umol/l)
- Current or previously evidence of ascites on CT-scan or physical examination
- Tumour volume greater than 50% of liver volume
- Conditions precluding translational samples
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Denmark · 1 center
- Department of Oncology, Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT04491929 · 1-10-72-111-20