Hepatocellular CarcinomaNCT00746655
SBRT + TACE for Primary Hepatocellular Carcinoma
A study testing Stereotactic Body Radiation Therapy (SBRT) and Transcatheter Arterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by University of Pittsburgh at 4 sites in United States.
Trial summary
The purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Transcatheter Arterial Chemoembolization (TACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Dec 2015
- 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
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix III)
- HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the following criteria must be met or a biopsy is required: • Known cirrhosis or chronic HBV or HCV infection, • Hypervascular liver masses >2 cm, and either serum AFP > 400 ng/ml, or • AFP >three times normal and doubling in value in the antecedent 3 months.
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.
- No prior radiotherapy to the liver.
- Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan.
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- Cirrhotic status of Child-Pugh class A or B (Appendix I)
- Patient's lesions are deemed unresectable.
- Patient's tumor burden or medical comorbidities disqualify them for transplant OR the patient qualifies for transplant but refuses the operation OR patients planned for TACE as a bridge to transplant operation.
- Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) ≤ 1.5 or a PT/PTT within normal limits. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
- Other baseline labs must meet the following criteria: total bilirubin <3mg/dl, albumin>2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be <1.8mg/dl or a creatinine clearance >50ml/min.
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Who cannot join
- Renal failure requiring hemo- or peritoneal dialysis
- Uncontrolled inter-current illness (except Hepatitis) including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted.
- A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement.
- History of an active connective tissue disorder.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects.
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- Total portal vein occlusion.
- Extensive liver tumor burden, defined as more than 75% of the liver.
- Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
- Patients with uncontrolled distant disease will be excluded from this protocol. Those with controlled systemic disease will still be eligible.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UPMC Presbyterian/Montifore
Pittsburgh, Pennsylvania, 15213
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Read the detailed description
Patients who are poor surgical candidates could potentially benefit from non-surgical alternatives such as stereotactic body radiation therapy (SBRT). SBRT is an ideal approach to minimize radiation exposure to the normal liver while maximizing the dose to the tumor. Transarterial chemoembolization (TACE) is the combined use of intra-arterial chemotherapy and particulate arterial embolization. This technique is typically used to make unresectable liver lesions amenable to resection, for palliation in cases of extra-hepatic spread or recurrence, or for symptomatic relief. The combination of intraarterial chemotherapy with vessel embolization makes logical sense since primary and secondary liver tumors derive up to 95% of their blood supply from the hepatic artery, while the normal liver gains the majority of its blood supply from the portal system. Thus, using transarterial chemoembolization it is possible to achieve high intratumor drug concentrations followed by local ischemia, allowing uninvolved liver to be spared. This study is to determine that these standard of care therapies combined to improve the quality of life for the patient population.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Transcatheter Arterial Chemoembolization (TACE)
- Keywords
- Hepatocellular
- 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)Radiation
Also called CyberKnife, Trilogy
The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
Transcatheter Arterial Chemoembolization (TACE)Procedure or surgery
Also called Cisplatin
. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
| Study group | Role | What they receive |
|---|---|---|
| SBRT / TACE | Other | Not described Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Transcatheter Arterial Chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and toxicity of combining SBRT and TACE for HCC.
Measured: Until disease progression
To evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Measured: Until disease progression
Secondary outcomes (3)
To determine local response of combination therapy with PET/CT and CT only.
Measured: Every 8 weeks
To evaluate the progression free interval associated with this local regional therapy.
Measured: Until disease progression
To determine if SBRT and TACE will be able to bridge patients to transplant that were initially ineligible.
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startJul 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwight Heron, University of Pittsburgh
- Investigators
- Dwight E Heron, MD, Study chair, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746655
- Sponsor's protocol ID
- 08-042
- Status last verified
- Dec 2015
- First submitted
- 2 Sep 2008
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00746655
- Acronym / sponsor ID
- 08-042
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2008 (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 purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Detailed description
Patients who are poor surgical candidates could potentially benefit from non-surgical alternatives such as stereotactic body radiation therapy (SBRT). SBRT is an ideal approach to minimize radiation exposure to the normal liver while maximizing the dose to the tumor. Transarterial chemoembolization (TACE) is the combined use of intra-arterial chemotherapy and particulate arterial embolization. This technique is typically used to make unresectable liver lesions amenable to resection, for palliation in cases of extra-hepatic spread or recurrence, or for symptomatic relief. The combination of intraarterial chemotherapy with vessel embolization makes logical sense since primary and secondary liver tumors derive up to 95% of their blood supply from the hepatic artery, while the normal liver gains the majority of its blood supply from the portal system. Thus, using transarterial chemoembolization it is possible to achieve high intratumor drug concentrations followed by local ischemia, allowing uninvolved liver to be spared. This study is to determine that these standard of care therapies combined to improve the quality of life for the patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT / TACE | Other | Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Transcatheter Arterial Chemoembolization (TACE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix III)
- HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the following criteria must be met or a biopsy is required: • Known cirrhosis or chronic HBV or HCV infection, • Hypervascular liver masses >2 cm, and either serum AFP > 400 ng/ml, or • AFP >three times normal and doubling in value in the antecedent 3 months.
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.
- No prior radiotherapy to the liver.
Key exclusion criteria (10 listed)
- Renal failure requiring hemo- or peritoneal dialysis
- Uncontrolled inter-current illness (except Hepatitis) including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted.
- A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement.
- History of an active connective tissue disorder.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
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: CyberKnife, TrilogyThe first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period, | Radiation | SBRT / TACE |
| Transcatheter Arterial Chemoembolization (TACE)Also: Cisplatin. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery. | Procedure or surgery | SBRT / TACE |
Primary outcome
To determine the feasibility and toxicity of combining SBRT and TACE for HCC.
Time frame: Until disease progression
To evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Time frame: Until disease progression
3 secondary outcomes
To determine local response of combination therapy with PET/CT and CT only.
Time frame: Every 8 weeks
To evaluate the progression free interval associated with this local regional therapy.
Time frame: Until disease progression
To determine if SBRT and TACE will be able to bridge patients to transplant that were initially ineligible.
Time frame: Until disease progression
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 24 Dec 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.
Dwight E Heron, MD study chair
University of Pittsburgh Medical Center
4 sites 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 (SBRT) and Transcatheter Arterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by University of Pittsburgh at 4 sites 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 12 inclusion and 10 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
To determine the feasibility and toxicity of combining SBRT and TACE for HCC. (time frame: Until disease progression). The study lists 2 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 24 Dec 2015.