Clinical trial NCT02820194: 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
Overall status: TERMINATED
Phase: NA
Conditions: Secondary Malignant Neoplasm of Liver
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Control of local disease
timeFrame: 18 months
Secondary outcomes:
measure: Progression free-survival of treated patients
timeFrame: 18 months
measure: Overall survival of treated patients
timeFrame: 18 months
measure: Incidence of acute and late complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Humanitas Cancer Center
name: Marta Scorsetti, MD
role: PRINCIPAL_INVESTIGATOR
References: