A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)

NCT ID: NCT02820194

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-07-31

Brief Summary

The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA.

The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes.

Detailed Description

The trial is a monocentric prospective, randomised controlled, unblinded, parallel-group superiority trial of Stereotactic Body Radiation Therapy (SBRT) versus Microwave Ablation (MWA) for the curative treatment of inoperable colorectal liver metastases. Patients will be randomised on an equal basis to either SBRT or MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of local response rate and acute toxicity. Longer-term outcomes will concentrate on oncological aspects of the disease with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

Conditions

Secondary Malignant Neoplasm of Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic body radiation therapy

Patients are treated with Stereotactic Body Radiation Therapy, a methodology for delivering a conformal high dose of radiation to the tumor and a minimal dose to surrounding critical tissues, with a hypofractionation schedule.

Group Type: ACTIVE_COMPARATOR

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Stereotactic body radiation is a therapy for delivering a conformal high dose of radiation to the tumor and a minimal dose to surrounding critical tissues, with a hypofractionation schedule

Microwave Ablation

Patients are treated with Microwave Ablation,a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis.

Group Type: ACTIVE_COMPARATOR

Microwave Ablation

Intervention Type: PROCEDURE

Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis

Interventions

Stereotactic Body Radiation Therapy

Stereotactic body radiation is a therapy for delivering a conformal high dose of radiation to the tumor and a minimal dose to surrounding critical tissues, with a hypofractionation schedule

Intervention Type: RADIATION

Microwave Ablation

Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Karnofsky index >70%
• Histological proven adenocarcinoma of the colon or rectum with radiological (by CT- or MRI) or histological-/cytological verified liver metastases.
• Metastases must be visible on diagnostic- and dose planning CT scans and on ultrasonography.
• The patient should not be suitable for surgical resection due to technical or patient-related conditions. Resectability must be judged by a trained hepatobiliary surgeon and discussed in a multidisciplinary team meeting.
• Presence of 1-3 lesions .
• Diameter ≤ 40 mm.
• All tumors should be feasible for treatment with each of the two modalities, SBRT and MWA
• Adequate liver function: bilirubin <1.5 mg/dl, alb> 3.5g/dl, normal PT/PTT except if the patient uses anticoagulants, liver enzymes<3 times upper limit of normal. No ascites.
• Renal function must be adequate for infusion of iv. contrast for CT-scan.
• Adequate bone marrow function: Hbg³8 g/dl, platelets³100.000 and leucocytes ³2.000/ml.
• Informed consent.
• Extrahepatic disease stable or in response after CT
• No previous abdominal radiation therapy (RT)

Exclusion Criteria

• Uncontrolled primary tumor or extrahepatic disease
• Previous abdominal radiation therapy (RT) or other local conservative treatment on lesion target.
• Pregnant or breastfeeding patients.
• Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression).
• Previous inclusion in this study.
• Underlying liver cirrhosis (Child-Pugh grade B or C).
• Ascites and/or relevant intra-hepatic biliary tract dilatation.
• Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Scorsetti, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Cancer Center

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

1559

Identifier Type: -

Identifier Source: org_study_id