Hepatocellular Carcinoma (HCC)Early Phase 1RAD 0902NCT01247298
A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
A Early Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Hepatocellular Carcinoma (HCC), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis
- Patients meeting all the following criteria will be considered for enrollment:
- Pathologically confirmed HCC -OR
- HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200.
- Lesions:
- Single liver lesion: measuring 3 cm to ≤ 8 cm.
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- Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
- Lesions <3 cm if they are in an unfavorable location for ablation† *The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below.
- Patient
- Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA.
- Patient must be a candidate and receive TACE.
- ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-1.
- Age > 19
- Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception.
- Adequate hematological profile and adequate liver functions. Signed informed consent document
- Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- Prior invasive malignancies
- Prior radiotherapy to the liver or surrounding areas.
- Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT
- Severe medical co-morbidities
- INR (international normalized ratio) > 2 times upper level normal
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- Uncontrolled or symptomatic clinical ascites
- Major surgical procedure within 3 weeks prior to study entry.
- History of hypersensitivity to chemotherapy agents, contrast material.
- Pregnancy, breast-feeding or planning to become pregnant.
- Treatment with any investigational product in the last 4 weeks before study entry.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study.
- Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.
Read the detailed description
Primary objectives of this research
- Evaluate the safety of a combination of TACE and high dose SBRT
- Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE \& SBRT.
Secondary objectives of this research
- Assess failure patterns and survival of patients treated with TACE \& SBRT.
- Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- Hepatocellular Carcinoma (HCC), Trans-Arterial Chemobolizaion (TACE), Radiation Induced Liver Disease (RILD), Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Combination product
Also called TACE
This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.) Receives: Combination Product: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a Combination Therapy
Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.
Measured: Baseline to 45 day after completing combination treatment.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.
Measured: Baseline to up to 2 years after treatment completed
Local Recurrence Rate
Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.
Measured: Baseline to up to 2 years after treatment completed
Secondary outcomes (2)
Percentage of Participants With Overall Survival
Assess overall survival (OS) of patients treated with TACE \& SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
Measured: up to 2 years after treatment completed
Percentage of Participants With Local Failure Patterns
Assess local failure patterns of patients treated with TACE \& SBRT. This is assessed by the percentage of patients where recurrence occurred
Measured: Baseline up to 2 years after treatment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rojymon Jacob, University of Alabama at Birmingham
- Investigators
- Rojymon Jacob, MD, FRCR, Principal investigator, University of Alabama at Birmingham/Department of Radiation OncologyDerek A. Dubay, MD, Principal investigator, University of Alabama at Birmingham Department of Hepatobiliary Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247298
- Sponsor's protocol ID
- F100708009
- Acronym
- RAD 0902
- Status last verified
- Jul 2017
- First submitted
- 22 Nov 2010
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01247298
- Acronym / sponsor ID
- RAD 0902 / F100708009
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma (HCC), Trans-Arterial Chemobolizaion (TACE), Radiation Induced Liver Disease (RILD), Stereotactic Body Radiation Therapy (SBRT)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.
Detailed description
Primary objectives of this research
- Evaluate the safety of a combination of TACE and high dose SBRT
- Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE \& SBRT.
Secondary objectives of this research
- Assess failure patterns and survival of patients treated with TACE \& SBRT.
- Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Combination Product: Stereotactic Body Radiation Therapy (SBRT)Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis
- Pathologically confirmed HCC -OR
- HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200.
- Single liver lesion: measuring 3 cm to ≤ 8 cm.
- Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
Key exclusion criteria (14 listed)
- Prior invasive malignancies
- Prior radiotherapy to the liver or surrounding areas.
- Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT
- Severe medical co-morbidities
- INR (international normalized ratio) > 2 times upper level normal
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 Therapy (SBRT)Also: TACEThis investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy. | Combination product | Stereotactic Body Radiation Therapy (SBRT) |
Primary outcome
Safety of a Combination Therapy
Time frame: Baseline to 45 day after completing combination treatment.
Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
Time frame: Baseline to up to 2 years after treatment completed
Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.
Local Recurrence Rate
Time frame: Baseline to up to 2 years after treatment completed
Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.
2 secondary outcomes
Percentage of Participants With Overall Survival
Time frame: up to 2 years after treatment completed
Percentage of Participants With Local Failure Patterns
Time frame: Baseline up to 2 years after treatment completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rojymon Jacob, MD, FRCR principal investigator
University of Alabama at Birmingham/Department of Radiation Oncology
Derek A. Dubay, MD principal investigator
University of Alabama at Birmingham Department of Hepatobiliary Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Hepatocellular Carcinoma (HCC), run by University of Alabama at Birmingham at 1 site in United States.
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 16 inclusion and 14 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: finished, as of the sponsor's last update on 21 Aug 2017. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of a Combination Therapy (time frame: Baseline to 45 day after completing combination treatment.). The study lists 3 primary outcomes in all. 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 21 Aug 2017.