Liver MetastasesNCT01347333
Stereotactic Body Radiotherapy for Liver Tumors
A study testing Stereotactic body radiosurgery and Stereotactic Body Radiotherapy in people with Liver Metastases and Hepatocellular Carcinoma, run by Mercy Research at 1 site in United States.
Trial summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Stereotactic body radiosurgery and Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age >= 18 years
- Zubrod performance status of 0-3
- Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
- Unresectable hepatocellular carcinoma (HCC)
- Unresectable intrahepatic cholangiocarcinoma (IHCC)
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- Maximum tumor diameter < 6 cm
- Adequate liver function:
- Total bilirubin < 3 mg/dL Serum albumin > 2.5 g/dL Serum levels of liver enzymes < 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication
- Signed study-specific consent form
Who cannot join
- Maximum tumor diameter > 6 cm
- Prior radiotherapy to the liver
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. John's Mercy Medical Center
St Louis, Missouri, 63141
About this study
Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
Read the detailed description
This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
- Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- Metastases from neuroendocrine tumors with functional endocrine syndromes
- Unresectable hepatocellular carcinoma (HCC)
- Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
- Being tested
- Stereotactic body radiosurgery, Stereotactic Body Radiotherapy
- Keywords
- liver metastases, stereotactic radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiosurgeryRadiation
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
Stereotactic Body RadiotherapyRadiation
26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
| Study group | Role | What they receive |
|---|---|---|
| liver metastases | Other | Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Receives: Radiation: Stereotactic body radiosurgery |
| Primary Liver Tumors | Other | Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Recurrence Rate
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
Measured: 5 years
Secondary outcomes (1)
Late Complication Rates
Toxicities will be assessed using CTCAE grading criteria at specified timepoints.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startSep 2008
- Primary completionSep 2016
- Study completionSep 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 Liver MetastasesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy Baglan, MD, Mercy Research
- Investigators
- Bethany G Sleckman, MD, Study director, Mercy Hospital St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347333
- Sponsor's protocol ID
- 08-045
- Status last verified
- Feb 2020
- First submitted
- 2 May 2011
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
- ClinicalTrials.gov ID
- NCT01347333
- Acronym / sponsor ID
- 08-045
- Keywords
- liver metastases, stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
Detailed description
This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
- Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- Metastases from neuroendocrine tumors with functional endocrine syndromes
- Unresectable hepatocellular carcinoma (HCC)
- Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver metastases | Other | Radiation: Stereotactic body radiosurgeryOligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes |
| Primary Liver Tumors | Other | Radiation: Stereotactic Body RadiotherapyHepatocellular Carcinoma Intrahepatic Cholangiocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient age >= 18 years
- Zubrod performance status of 0-3
- Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
- Unresectable hepatocellular carcinoma (HCC)
Key exclusion criteria (4 listed)
- Maximum tumor diameter > 6 cm
- Prior radiotherapy to the liver
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
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 radiosurgery36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) | Radiation | liver metastases |
| Stereotactic Body Radiotherapy26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) | Radiation | Primary Liver Tumors |
Primary outcome
Local Tumor Recurrence Rate
Time frame: 5 years
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
1 secondary outcome
Late Complication Rates
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- 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.
Bethany G Sleckman, MD study director
Mercy Hospital St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiosurgery and Stereotactic Body Radiotherapy in people with Liver Metastases and Hepatocellular Carcinoma, run by Mercy Research 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 10 inclusion and 4 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 3 Mar 2020. 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 3 Mar 2020). 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?
Local Tumor Recurrence Rate (time frame: 5 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 3 Mar 2020.