Hepatocellular CarcinomaRAD 0901NCT01005875
Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma
A study testing Sorafenib and Stereotactic Body Radiotherapy (SBRT) in people with Hepatocellular Carcinoma and Liver Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug 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, Liver Cancer
- What is being tested?
- Sorafenib and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2013
- Phase
- Interventional
- 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
- Child-Pugh class A or B7 cirrhosis.
- No prior radiation therapy to the upper right abdominal quadrant.
- Size of each tumor less than 6 cm.
- Three or less known lesions.
- More than 800 cc of uninvolved liver.
- Age > 19 years old
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- ECOG Performance Status 0 or 1
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin > 8.5 g/dl
- Platelet count > 50,000/mm3
- Total bilirubin < 1.5 times ULN
- ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)
- Creatinine < 1.5 times ULN
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
Who cannot join
- Child-Pugh class B8 or C cirrhosis.
- ECOG greater than or equal to 2.
- Uncontrolled ascites despite medical management.
- Less than 800 cc of uninvolved liver.
- Prior radiotherapy to the upper abdominal quadrant.
- Prior antiangiogenic or tyrosine kinase inhibitor therapy Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina(anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
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- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
- Pregnant or lactating female.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma
This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- Sorafenib, Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Hepatocellular carcinoma, HCC, Liver Cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called BAY 43-9006, Nexavar
Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT)Radiation
SBRT
| Study group | Role | What they receive |
|---|---|---|
| Radiation followed by Sorafenib | Experimental | Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Receives: Drug: Sorafenib; Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib
Measured: between baseline and 3 years
Secondary outcomes (4)
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume
mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment
Measured: baseline, 4 weeks and 10 weeks
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).
The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.
Measured: baseline, 4 weeks and 10 weeks
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.
The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.
Measured: baseline, 4 weeks after baseline and 10 weeks post baseline
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).
the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.
Measured: baseline, 4 weeks post baseline, 10 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionJun 2013
Why it stopped: Sponsor(Bayer)did not wish to continue with study due to slow accrual. Therefore, there is insufficient data and will not be any study results/outcomes.
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 CarcinomaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Principal investigator, Dr. Kimberly Keene, University of Alabama at Birmingham
- Investigators
- Kimberly S Keene, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005875
- Sponsor's protocol ID
- F090910004
- Acronym
- RAD 0901
- Status last verified
- Apr 2017
- First submitted
- 30 Oct 2009
- Last updated
- 10 May 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 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01005875
- Acronym / sponsor ID
- RAD 0901 / F090910004
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- Hepatocellular carcinoma, HCC, Liver Cancer, adult primary hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor(Bayer)did not wish to continue with study due to slow accrual. Therefore, there is insufficient data and will not be any study results/outcomes.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation followed by Sorafenib | Experimental | Drug: Sorafenib, Radiation: Stereotactic Body Radiotherapy (SBRT)Radiation therapy, stereotactic body radiation therapy followed by Sorafenib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Child-Pugh class A or B7 cirrhosis.
- No prior radiation therapy to the upper right abdominal quadrant.
- Size of each tumor less than 6 cm.
- Three or less known lesions.
- More than 800 cc of uninvolved liver.
Key exclusion criteria (22 listed)
- Child-Pugh class B8 or C cirrhosis.
- ECOG greater than or equal to 2.
- Uncontrolled ascites despite medical management.
- Less than 800 cc of uninvolved liver.
- Prior radiotherapy to the upper abdominal quadrant.
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 |
|---|---|---|
| SorafenibAlso: BAY 43-9006, NexavarNexavar in bottles of 120 tables | Drug | Radiation followed by Sorafenib |
| Stereotactic Body Radiotherapy (SBRT)SBRT | Radiation | Radiation followed by Sorafenib |
Primary outcome
Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Time frame: between baseline and 3 years
Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib
4 secondary outcomes
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume
Time frame: baseline, 4 weeks and 10 weeks
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).
Time frame: baseline, 4 weeks and 10 weeks
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.
Time frame: baseline, 4 weeks after baseline and 10 weeks post baseline
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).
Time frame: baseline, 4 weeks post baseline, 10 weeks post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
Kimberly S Keene, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorafenib and Stereotactic Body Radiotherapy (SBRT) in people with Hepatocellular Carcinoma and Liver Cancer, 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 17 inclusion and 22 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 10 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2014). 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?
Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma (time frame: between baseline and 3 years). 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 10 May 2017.