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

A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)

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.

Study Overview

• Status: Terminated
• Conditions: Secondary Malignant Neoplasm of Liver
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy; Procedure: Microwave Ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Radiation: 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
Active Comparator: Microwave Ablation; Patients are treated with Microwave Ablation,a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis.	Procedure: Microwave Ablation; Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control of local disease	Evaluation of proportion of patients free from progression from starting radiotherapy	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free-survival of treated patients	Evaluation of proportion of patients alive and free from progression	18 months
Overall survival of treated patients	Evaluation of proportion of patients alive	18 months
Incidence of acute and late complications	Evaluation of early and late post treatment complications	18 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Marta Scorsetti, MD, Humanitas Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplasms; Liver Neoplasms
• Other Study ID Numbers: 1559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO