Carcinoma, HepatocellularTACE-SBRTNCT02304445
Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer
A study testing Transarterial Chemoembolization (TACE) and TACE+Stereotactic Body Radiotherapy in people with Carcinoma, Hepatocellular, run by Juan Sanabria, MD.
Trial summary
This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Transarterial Chemoembolization (TACE) and TACE+Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma (Barcelona Stage B or C)
- Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
- Age ≥ 18 years and ≤ 70 years
- Eastern Cooperative Oncology Group Performance status ≤ 2
- Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
- Hemoglobin > 10.0 g/dL
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- Total bilirubin > 3.0 mg/dL
- AST (SGOT) ≤ 3x institutional upper limit of normal
- ALT (SGPT) ≤ 3x institutional upper limit of normal
- Absolute neutrophil count ≥ 1,500/μl
- Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
- Aggregate maximal dimension of liver tumors ≤ 8 cm
- Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
- Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
- Life expectancy ≥ 12 weeks
- Ability to understand study and provide legally effective written informed consent
- Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child
- Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization
Who cannot join
- History of abdominal radiation
- Cirrhosis classified as Child Pugh Class B with score ≥ 8
- Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Evidence of metastatic disease prior to registration
- Evidence of main portal vein thrombosis
- History of cardiac ischemia or stroke within 6 months prior to enrollment
- Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
- History of sorafenib therapy within 21 days prior to enrollment
About this study
Official title: Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Transarterial Chemoembolization (TACE), TACE+Stereotactic Body Radiotherapy
- Keywords
- Radiotherapy, Chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial Chemoembolization (TACE)Procedure or surgery
TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
TACE+Stereotactic Body RadiotherapyRadiation
This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial Chemoembolization (TACE) | Active comparator | Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated. Receives: Procedure: Transarterial Chemoembolization (TACE) |
| TACE+Stereotactic Body Radiotherapy | Experimental | Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments. Receives: Procedure: Transarterial Chemoembolization (TACE); Radiation: TACE+Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months
Measured: 3 months
Secondary outcomes (4)
Tumor down staging
Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months
Measured: 3 and 6 months
Frequency of adverse events
Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors
Measured: 6 months
Incidence of local tumor progression
Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)
Measured: 6 months
Number of patients eligibility for liver transplantation
Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Necessary equipment could not be obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Sanabria, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Sanabria, MD, Midwestern Regional Medical Center
- Investigators
- Juan Sanabria, MD, Principal investigator, Midwestern Reginal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304445
- Sponsor's protocol ID
- MZ2014022
- Acronym
- TACE-SBRT
- Status last verified
- Nov 2015
- First submitted
- 26 Nov 2014
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02304445
- Acronym / sponsor ID
- TACE-SBRT / MZ2014022
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Radiotherapy, Chemoembolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Necessary equipment could not be obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juan Sanabria, MDUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 2 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.
This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarterial Chemoembolization (TACE) | Active comparator | Procedure: Transarterial Chemoembolization (TACE)Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated. |
| TACE+Stereotactic Body Radiotherapy | Experimental | Procedure: Transarterial Chemoembolization (TACE), Radiation: TACE+Stereotactic Body RadiotherapySubjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Hepatocellular carcinoma (Barcelona Stage B or C)
- Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
- Age ≥ 18 years and ≤ 70 years
- Eastern Cooperative Oncology Group Performance status ≤ 2
- Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
Key exclusion criteria (8 listed)
- History of abdominal radiation
- Cirrhosis classified as Child Pugh Class B with score ≥ 8
- Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Evidence of metastatic disease prior to registration
- Evidence of main portal vein thrombosis
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 |
|---|---|---|
| Transarterial Chemoembolization (TACE)TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible. | Procedure or surgery | TACE+Stereotactic Body Radiotherapy, Transarterial Chemoembolization (TACE) |
| TACE+Stereotactic Body RadiotherapyThis intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors. | Radiation | TACE+Stereotactic Body Radiotherapy |
Primary outcome
Tumor response rate
Time frame: 3 months
Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months
4 secondary outcomes
Tumor down staging
Time frame: 3 and 6 months
Frequency of adverse events
Time frame: 6 months
Incidence of local tumor progression
Time frame: 6 months
Number of patients eligibility for liver transplantation
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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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.
Juan Sanabria, MD principal investigator
Midwestern Reginal Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial Chemoembolization (TACE) and TACE+Stereotactic Body Radiotherapy in people with Carcinoma, Hepatocellular, run by Juan Sanabria, MD.
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 18 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: withdrawn, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Tumor response rate (time frame: 3 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 26 Nov 2015.