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

Primary Purpose

Secondary Malignant Neoplasm of Liver

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Microwave Ablation
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Malignant Neoplasm of Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Humanitas Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stereotactic body radiation therapy

Microwave Ablation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Control of local disease
Evaluation of proportion of patients free from progression from starting radiotherapy

Secondary Outcome Measures

Progression free-survival of treated patients
Evaluation of proportion of patients alive and free from progression
Overall survival of treated patients
Evaluation of proportion of patients alive
Incidence of acute and late complications
Evaluation of early and late post treatment complications

Full Information

First Posted
June 24, 2016
Last Updated
September 14, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02820194
Brief Title
A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)
Official Title
A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
not sufficient patient recruited
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Malignant Neoplasm of Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic body radiation therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Microwave Ablation
Arm Type
Active Comparator
Arm Description
Patients are treated with Microwave Ablation,a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
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
Procedure
Intervention Name(s)
Microwave Ablation
Intervention Description
Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis
Primary Outcome Measure Information:
Title
Control of local disease
Description
Evaluation of proportion of patients free from progression from starting radiotherapy
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progression free-survival of treated patients
Description
Evaluation of proportion of patients alive and free from progression
Time Frame
18 months
Title
Overall survival of treated patients
Description
Evaluation of proportion of patients alive
Time Frame
18 months
Title
Incidence of acute and late complications
Description
Evaluation of early and late post treatment complications
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Scorsetti, MD
Organizational Affiliation
Humanitas Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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