Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver

Rigshospitalet

Status and phase: Active, not recruiting; Phase 2

Conditions: Colorectal Carcinoma; Liver Metastases

Treatments: Device: MWA; Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03654131

H-18000085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

   1. non-resectability
   2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
   3. previous extensive liver surgery
   4. comorbidity

2. 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.

3. Tumor sizes ≤4.0 cm

4. Age > 18 years

5. Signed informed consent

Exclusion criteria

1. Previous radiotherapy to the liver
2. Liver volume < 700 ml
3. Another active cancer disease within the past 36 months
4. Not able to understand written or oral protocol information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

MWA

Active Comparator group

Description:

Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.

Treatment:

Device: MWA

SBRT

Active Comparator group

Description:

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.

Treatment:

Radiation: SBRT