Hepatocellular CarcinomaNCT02323360
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
A study testing SBRT and TACE in people with Hepatocellular Carcinoma, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SBRT and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Oct 2019
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Karnofsky index >70%
- Child-Turgotte-Pugh A or B liver score.
- An initial diagnosis of primary HCC or recurrence.
- A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
- HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
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- Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
- Hb >10.5.0 g/%, WBC >3.000 cells/mm3, platelets >50.000 cells/mm3, bilirubin <2 mg/dl, aspartate and alanine aminotransferase levels <5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
- Serum creatinine <1.7 mg/dl
- Previously incomplete TAE or TACE with radiologically defined residual disease.
- Informed consent
Who cannot join
- Extrahepatic disease and refractory ascites.
- Previous abdominal radiation therapy (RT)
- Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
- Pregnant or breastfeeding patients.
- Patients with uncontrolled infections or HIV seropositive patients.
- 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 Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)
The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.
Read the detailed description
In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- SBRT, TACE, TAE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic body radiation therapy
Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions
TACEProcedure or surgery
Also called Transcatheter arterial chemoembolization
Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to a new cycle of TAE or TACE
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | HCC after incomplete TAE or TACE treated by SBRT Receives: Radiation: SBRT |
| TACE/TAE | Active comparator | HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.
Measured: 1.5 years
Secondary outcomes (3)
progression free-survival
Measured: 1.5 years
overall survival
Measured: 1.5 years
toxicity (incidence of acute and late complications)
incidence of acute and late complications
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: too slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323360
- Sponsor's protocol ID
- 1315
- Status last verified
- Oct 2019
- First submitted
- 11 Dec 2014
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Comito T, Loi M, Franzese C, Clerici E, Franceschini D, Badalamenti M, Teriaca MA, Rimassa L, Pedicini V, Poretti D, Solbiati LA, Torzilli G, Ceriani R, Lleo A, Aghemo A, Santoro A, Scorsetti M. Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360). Curr Oncol. 2022 Nov 16;29(11):8802-8813. doi: 10.3390/curroncol29110692.
PubMed 36421345
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02323360
- Acronym / sponsor ID
- 1315
- Conditions
- Hepatocellular Carcinoma
- Keywords
- SBRT, TACE, TAE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too slow enrollment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 23 Dec 2014 (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 a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.
Detailed description
In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.
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 | Experimental | Radiation: SBRTHCC after incomplete TAE or TACE treated by SBRT |
| TACE/TAE | Active comparator | Procedure: TACEHCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >18 years
- Karnofsky index >70%
- Child-Turgotte-Pugh A or B liver score.
- An initial diagnosis of primary HCC or recurrence.
- A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
Key exclusion criteria (6 listed)
- Extrahepatic disease and refractory ascites.
- Previous abdominal radiation therapy (RT)
- Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
- Pregnant or breastfeeding patients.
- Patients with uncontrolled infections or HIV seropositive patients.
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 |
|---|---|---|
| SBRTAlso: Stereotactic body radiation therapyPatients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions | Radiation | Stereotactic body radiation therapy |
| TACEAlso: Transcatheter arterial chemoembolizationPatients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to a new cycle of TAE or TACE | Procedure or surgery | TACE/TAE |
Primary outcome
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
Time frame: 1.5 years
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.
3 secondary outcomes
progression free-survival
Time frame: 1.5 years
overall survival
Time frame: 1.5 years
toxicity (incidence of acute and late complications)
Time frame: 1.5 years
Results and safety
The study was stopped early (reason given: too slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 36421345Comito T, Loi M, Franzese C, Clerici E, Franceschini D, Badalamenti M, Teriaca MA, Rimassa L, Pedicini V, Poretti D, Solbiati LA, Torzilli G, Ceriani R, Lleo A, Aghemo A, Santoro A, Scorsetti M. Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360). Curr Oncol. 2022 Nov 16;29(11):8802-8813. doi: 10.3390/curroncol29110692.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT and TACE in people with Hepatocellular Carcinoma, 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 11 inclusion and 6 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 25 Oct 2019. 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: too slow enrollment). 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?
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE) (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323360, which also lists 1 linked publication.
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 25 Oct 2019.