Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver
- Conditions
- Colorectal CarcinomaLiver Metastases
- Interventions
- Device: MWARadiation: SBRT
- Registration Number
- NCT03654131
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
This study is a randomized phase II trial between microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. Primary endpoint is freedom form local lesion progression.
- Detailed Description
Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of
- non-resectability
- small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
- previous extensive liver surgery
- comorbidity
-
The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
-
Tumor sizes ≤4.0 cm
-
Age > 18 years
-
Signed informed consent
- Previous radiotherapy to the liver
- Liver volume < 700 ml
- Another active cancer disease within the past 36 months
- Not able to understand written or oral protocol information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MWA MWA Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment. SBRT SBRT 3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.
- Primary Outcome Measures
Name Time Method Freedom from local lesion progression (analyzed on patient-level) 3 years * Defined as the time from randomization to local progression
* Censoring: death from any cause, last follow-up
* No censoring on disease progression outside of the treated lesions
* Local lesion progression is defined as \>20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
- Secondary Outcome Measures
Name Time Method Overall survival 3 years * Defined as the time from randomization to death from any cause
* Censoring: last follow-upFreedom from local lesion progression (analyzed on lesion-level) 3 years * Defined as the time from randomization to local progression
* Censoring: death from any cause, last follow-up
* No censoring on disease progression outside of the treated lesions
* Local lesion progression is defined as \>20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions≥ grade 3 toxicity potentially associated with the treatment 3 years * Defined as the time from randomization to first ≥ grade 3 toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Censoring: death from any cause, last follow-upToxicity profile as descriptive statistics 3 years Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Quality of life as descriptive statistics: EORTC QLQ-C30 3 years Using EORTC QLQ-C30
Trial Locations
- Locations (1)
Righospitalet
🇩🇰Copenhagen, Denmark