Liver CancerPhase 2NCT01522937
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
A Phase 2 study testing individualized Stereotactic Body Radiation Therapy (SBRT) in people with Liver Cancer and Hepatocellular Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Cancer
- What is being tested?
- individualized Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2015
- Phase
- Phase 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
- over age 18
- life expectancy of at least 12 weeks
- Zubrod performance status of ≤2.
- biopsy proven hepatocellular carcinoma (HCC)
- liver metastases
- a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL
Show all 11Show fewer
- a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter
- adequate organ function
- women and men not interested in pregnancy
- must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
- minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.
Who cannot join
- cannot be eligible for a curative liver resection
- uncontrolled ascites clinically evident on physical exam
- known allergy to IC-Green
- known allergy to intravenous iodinated contrast agents
- patients with poor venous access
- patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-5010
About this study
Official title: A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
Read the detailed description
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.
- Conditions
- Liver Cancer, Hepatocellular Cancer
- Being tested
- individualized Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized Stereotactic Body Radiation Therapy (SBRT)Radiation
The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Liver cancer patients | Experimental | The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). Receives: Radiation: individualized Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Local Control at 1 Year Post Treatment
For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.
Measured: 1 Year
Secondary outcomes (4)
The Percentage of Patients Alive Without Progression at 1 Year
Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement
Measured: 1 Year
The Percentage of Patients Alive at 1 Year
Measured: 1 Year
The Number of Patients Who Experience Grade 4+ Hepatotoxicity
Grade 4 toxicities are life threatening toxicities that require urgent attention.
Measured: 1 Year
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
Grade 4 toxicities are life threatening toxicities that require urgent attention.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startOct 2009
- Primary completionNov 2015
- Study completionNov 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Cuneo, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522937
- Sponsor's protocol ID
- UMCC 2009-053
- Other IDs
- HUM00029467
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2011
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Feng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303.
PubMed 28796864
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
- ClinicalTrials.gov ID
- NCT01522937
- Acronym / sponsor ID
- UMCC 2009-053
- Conditions
- Liver Cancer, Hepatocellular Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 9 Mar 2017
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 Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
Detailed description
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver cancer patients | Experimental | Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- over age 18
- life expectancy of at least 12 weeks
- Zubrod performance status of ≤2.
- biopsy proven hepatocellular carcinoma (HCC)
- liver metastases
Key exclusion criteria (6 listed)
- cannot be eligible for a curative liver resection
- uncontrolled ascites clinically evident on physical exam
- known allergy to IC-Green
- known allergy to intravenous iodinated contrast agents
- patients with poor venous access
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 |
|---|---|---|
| individualized Stereotactic Body Radiation Therapy (SBRT)The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment. | Radiation | Liver cancer patients |
Primary outcome
The Percentage of Patients With Local Control at 1 Year Post Treatment
Time frame: 1 Year
For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.
4 secondary outcomes
The Percentage of Patients Alive Without Progression at 1 Year
Time frame: 1 Year
The Percentage of Patients Alive at 1 Year
Time frame: 1 Year
The Number of Patients Who Experience Grade 4+ Hepatotoxicity
Time frame: 1 Year
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28796864Feng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303.
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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.
Kyle Cuneo, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing individualized Stereotactic Body Radiation Therapy (SBRT) in people with Liver Cancer and Hepatocellular Cancer, run by University of Michigan Rogel Cancer Center 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 11 inclusion and 6 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 9 Mar 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?
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 9 Mar 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?
The Percentage of Patients With Local Control at 1 Year Post Treatment (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522937, which also lists 1 linked publication.
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 9 Mar 2017.