C18 C19 C20
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Histologically confirmed colorectal cancer with liver, lung and / or lymph node metastases • progression after chemotherapy • No more than 2 members with active disease • primary tumor resected, no evidence of local recurrence • diameter of the largest liver lesion max. 5 cm, not more than five liver metastases OR Diameter of the largest lesion 15cm, not more than three liver metastases (Satellite metastases near the target lesion excluded) • No more than three lung metastases with a diameter of max. 5cm OR not more than five lesions up to 3 cm diameter • No more than two distant metastases outside the lung and liver (except bone metastases) • ECOG performance status = 1 • Karnofsky Index = 70%
Exclusion criteria
Exclusion criteria: • Cerebral metastasis • Symptomatic bone metastasis • peritoneal, pleural carcinosis • Other malignant diseases • Life expectancy <6 months • violation of an inclusion criterion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival after local percutaneous ablation of colorectal liver and lung metastases in patients with progression under first-line (second/thrid line) chemotherapy compared to survival without progression of systemically treated patients group as part of a matched-pair analysis (diagnostic imaging, clinical data and questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Effectiveness/local tumor control (follow up CT and/or MRI every 3 months) - Overall survival and quality of life (EQ-5D) of patients (clinical data, questionnaire every 3 months) - these results will be associated with results from collected blood and tissue samples to identify prognostic factors (e.g. microsatellite instability, mutation status: kras/nras/braf, micro-RNA in blodd and tissue) | — |
Countries
Germany
Contacts
Klinik für Radiologie und Nuklearmedizin