Colorectal Carcinoma, Liver Metastases
Conditions
Keywords
Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation
Brief summary
This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases. Primary end point is local progression free survival.
Detailed description
Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.
Interventions
PROCEDURESBRT or RFA
Patients are allocated to one of the two arms in a 1:1 randomization
Sponsors
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the colon or rectum * Liver metastases * Inoperable (technical or medical) * 1-4 metastases * Maximum 40 mm in diameter * Suitable for both therapies, RFA and SBRT
Exclusion criteria
* Uncontrolled extrahepatic disease and uncontrolled primary cancer * Liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local progression-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 3 years |
| Survival | 3 years |
| Progression (local or distant) | 3 years |
| Quality of life | 3 years |
Countries
Denmark, Sweden
Outcome results
None listed