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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2029-12-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Carcinoma Liver Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SBRT for oligometastases in the liver from colorectal cancer patients. Standard considered MWA.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MWA

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

Group Type ACTIVE_COMPARATOR

MWA

Intervention Type DEVICE

Patients are allocated to one of the two arms in a 1:1 randomization

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.

Group Type ACTIVE_COMPARATOR

SBRT

Intervention Type RADIATION

Patients are allocated to one of the two arms in a 1:1 randomization

Interventions

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MWA

Patients are allocated to one of the two arms in a 1:1 randomization

Intervention Type DEVICE

SBRT

Patients are allocated to one of the two arms in a 1:1 randomization

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No