Secondary Malignant Neoplasm of LiverNCT02820194
A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)
A study testing Stereotactic Body Radiation Therapy and Microwave Ablation in people with Secondary Malignant Neoplasm of Liver, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Malignant Neoplasm of Liver
- What is being tested?
- Stereotactic Body Radiation Therapy and Microwave Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Show all 14Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Secondary Malignant Neoplasm of Liver
- Being tested
- Stereotactic Body Radiation Therapy, Microwave Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
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
Microwave AblationProcedure or surgery
Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of local disease
Evaluation of proportion of patients free from progression from starting radiotherapy
Measured: 18 months
Secondary outcomes (3)
Progression free-survival of treated patients
Evaluation of proportion of patients alive and free from progression
Measured: 18 months
Overall survival of treated patients
Evaluation of proportion of patients alive
Measured: 18 months
Incidence of acute and late complications
Evaluation of early and late post treatment complications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2022
- Study completionJul 2022
Why it stopped: not sufficient patient recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of LiverStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Marta Scorsetti, MD, Principal investigator, Humanitas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820194
- Sponsor's protocol ID
- 1559
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2016
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)
- ClinicalTrials.gov ID
- NCT02820194
- Acronym / sponsor ID
- 1559
- Conditions
- Secondary Malignant Neoplasm of Liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not sufficient patient recruited
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Active comparator | Radiation: Stereotactic Body Radiation TherapyPatients 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. |
| Microwave Ablation | Active comparator | Procedure: Microwave AblationPatients are treated with Microwave Ablation,a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation TherapyStereotactic 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 | Radiation | Stereotactic body radiation therapy |
| Microwave AblationMicrowave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis | Procedure or surgery | Microwave Ablation |
Primary outcome
Control of local disease
Time frame: 18 months
Evaluation of proportion of patients free from progression from starting radiotherapy
3 secondary outcomes
Progression free-survival of treated patients
Time frame: 18 months
Overall survival of treated patients
Time frame: 18 months
Incidence of acute and late complications
Time frame: 18 months
Results and safety
The study was stopped early (reason given: not sufficient patient recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Secondary Malignant Neoplasm of Liver
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Scorsetti, MD principal investigator
Humanitas Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy and Microwave Ablation in people with Secondary Malignant Neoplasm of Liver, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not sufficient patient recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of local disease (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.