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

NCT02820194 | Terminated DMC

• 1 other identifier: 1559
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Malignant Neoplasm of Liver

Outcome Measures

Primary Outcomes (1)

• Control of local disease

  Evaluation of proportion of patients free from progression from starting radiotherapy

  18 months

Secondary Outcomes (3)

• Progression free-survival of treated patients

  18 months

• Overall survival of treated patients

  18 months

• Incidence of acute and late complications

  18 months

Study Arms (2)

Stereotactic body radiation therapy

ACTIVE COMPARATOR

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

Microwave Ablation

ACTIVE COMPARATOR

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

Interventions

Stereotactic Body Radiation Therapy 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

Stereotactic body radiation therapy

Microwave Ablation PROCEDURE

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

Microwave Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marta Scorsetti, MD

  Humanitas Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)