Carcinoma, HepatocellularPhase 1/2NCT01020812
Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma
A Phase 1/2 study testing TACE and SBRT in people with Carcinoma, Hepatocellular and Hepatobiliary Neoplasm, run by Stanford University at 1 site in United States.
Trial summary
To determine the efficacy and toxicity of TACE combined with SBRT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Hepatobiliary Neoplasm, Liver Carcinoma
- What is being tested?
- TACE and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2014
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension.
- 800 cc of uninvolved liver
- Patients may have additional hepatic lesions if they are <3cm and can be treated with TACE or RFA.
- Age > 18 years old
- Albumin > 2.4 g/dL.
- Total bilirubin < 3 mg/dL.
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- INR ≤ 1.5.
- Creatinine < 2.0 mg/dL.
- Confirmed hepatocellular carcinoma by one of the following:
- Histopathology
- Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion >2 cm with arterial hypervascularization
- One radiographic technique that confirms a lesion >2 cm with arterial hypervascularization and an elevated AFP
- Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure
- Tumor(s) <10cm
- Eastern Clinical Oncology Group performance status 0, 1 or 2
- No prior surgery, chemotherapy, or radiation for the current tumor
- Patients placed on the liver transplant registry are eligible for this trial, but will be withdrawn from the protocol if they receive liver transplantation.
- TACE done prior to study enrollment is allowed if there were no more than 3 procedures within an 18 week period and SBRT can begin within 12 weeks of the last TACE procedure.
Who cannot join
- Prior radiotherapy to the upper abdomen
- Prior TACE, RFA, or liver transplant
- Tumor(s) ≥ 10cm
- Large esophageal varices without band ligation
- Active GI bleed or within 2 weeks of study enrollment
- Ascites refractory to medical therapy
Show all 11Show fewer
- Contraindication to receiving radiotherapy
- Women who are pregnant
- Administration of any systemic cytotoxic agents within the last 12 months
- Presence of extrahepatic metastases
- Participation in another concurrent treatment protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma
To determine the efficacy and toxicity of TACE combined with SBRT
Read the detailed description
Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Outcome of this disease is poor, mostly due to the fact that >80% of patients present with unresectable disease. Surgery or transplantation remain the only curative options. For the vast majority of patients who are unresectable, a variety of treatment options are available, including transarterial chemo-embolization (TACE), radiofrequency ablation, radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of great improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated radiotherapy as a means of intensifying local therapy, with some evidence of benefit.
TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. The recent randomized trial suggests that a combination of local therapy (TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing proof of principle that combined local treatment is most likely more effective for HCC. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Studies combining TACE and external beam radiotherapy have shown encouraging results, so the logical next step is to combine TACE with SBRT, which delivers a radiobiologically more intensive dose of radiation. However, toxicity data are lacking, since this combination has not been previously reported.
We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for unresectable HCC.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called Transcatheter arterial chemoembolization, Transarterial Chemoembolization
Standard of Care
SBRTProcedure or surgery
Also called stereotactic body radiotherapy
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Experimental | SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction Receives: Procedure: TACE; Procedure: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Local Progression of TACE and SBRT at 12 Months
Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.
Measured: 12 months
Secondary outcomes (3)
To Determine the Progression-free Survival of TACE and SBRT at 18 Months
Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.
Measured: 18 months
To Determine the Overall Survival of TACE and SBRT at 18 Months
Overall survival is defined as the time from the start of treatment until death from any cause.
Measured: 18 months
Median Progression Free Survival
Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: enrollment was too low
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 Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel T. Chang, Stanford University
- Investigators
- Daniel T Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020812
- Sponsor's protocol ID
- HEP0024
- Other IDs
- SU-09112009-3882
- Status last verified
- Jun 2016
- First submitted
- 24 Nov 2009
- Last updated
- 27 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01020812
- Acronym / sponsor ID
- HEP0024
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment was too low
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Posted 22 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and toxicity of TACE combined with SBRT
Detailed description
Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Outcome of this disease is poor, mostly due to the fact that >80% of patients present with unresectable disease. Surgery or transplantation remain the only curative options. For the vast majority of patients who are unresectable, a variety of treatment options are available, including transarterial chemo-embolization (TACE), radiofrequency ablation, radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of great improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated radiotherapy as a means of intensifying local therapy, with some evidence of benefit.
TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. The recent randomized trial suggests that a combination of local therapy (TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing proof of principle that combined local treatment is most likely more effective for HCC. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Studies combining TACE and external beam radiotherapy have shown encouraging results, so the logical next step is to combine TACE with SBRT, which delivers a radiobiologically more intensive dose of radiation. However, toxicity data are lacking, since this combination has not been previously reported.
We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for unresectable HCC.
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 radiotherapy (SBRT) | Experimental | Procedure: TACE, Procedure: SBRTSBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension.
- Age > 18 years old
- Albumin > 2.4 g/dL.
- Total bilirubin < 3 mg/dL.
- INR ≤ 1.5.
Key exclusion criteria (11 listed)
- Prior radiotherapy to the upper abdomen
- Prior TACE, RFA, or liver transplant
- Tumor(s) ≥ 10cm
- Large esophageal varices without band ligation
- Active GI bleed or within 2 weeks of study enrollment
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 |
|---|---|---|
| TACEAlso: Transcatheter arterial chemoembolization, Transarterial ChemoembolizationStandard of Care | Procedure or surgery | Stereotactic body radiotherapy (SBRT) |
| SBRTAlso: stereotactic body radiotherapyStandard of Care | Procedure or surgery | Stereotactic body radiotherapy (SBRT) |
Primary outcome
Freedom From Local Progression of TACE and SBRT at 12 Months
Time frame: 12 months
Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.
3 secondary outcomes
To Determine the Progression-free Survival of TACE and SBRT at 18 Months
Time frame: 18 months
To Determine the Overall Survival of TACE and SBRT at 18 Months
Time frame: 18 months
Median Progression Free Survival
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- 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.
Daniel T Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TACE and SBRT in people with Carcinoma, Hepatocellular and Hepatobiliary Neoplasm, run by Stanford University 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 18 inclusion and 11 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 27 Jul 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 May 2015). 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?
Freedom From Local Progression of TACE and SBRT at 12 Months (time frame: 12 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 27 Jul 2016.