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

Secondary Malignant Neoplasm of Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02820194
• Other study ID #: 1559
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2022

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasms
• Secondary Malignant Neoplasm of Liver

Intervention

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

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

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of local disease	Evaluation of proportion of patients free from progression from starting radiotherapy	18 months
Secondary	Progression free-survival of treated patients	Evaluation of proportion of patients alive and free from progression	18 months
Secondary	Overall survival of treated patients	Evaluation of proportion of patients alive	18 months
Secondary	Incidence of acute and late complications	Evaluation of early and late post treatment complications	18 months