Adult Hepatocellular CarcinomaEarly Phase 1NCT02683200
MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer
A Early Phase 1 study testing Image-Guided Adaptive Radiation Therapy and Stereotactic Body Radiation Therapy in people with Adult Hepatocellular Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Hepatocellular Carcinoma, Metastatic Malignant Neoplasm in the Liver
- What is being tested?
- Image-Guided Adaptive Radiation Therapy and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2015to 1 Jan 2022
- Phase
- Early Phase 1
- 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
- Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
- Karnofsky performance status (KPS) >= 70
- No active infections requiring systemic antibiotics
- If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
- Ability to understand and willingness to sign a written informed consent
Who cannot join
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
- Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System
This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).
II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions.
SECONDARY OBJECTIVES:
- To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).
II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.
OUTLINE:
Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.
After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.
- Being tested
- Image-Guided Adaptive Radiation Therapy, Stereotactic Body Radiation Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Adaptive Radiation TherapyRadiation
Also called IGART
Undergo MRI-guided Tri-60Co teletherapy SBRT
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Undergo MRI-guided Tri-60Co teletherapy SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (MRI-guided Tri-60Co teletherapy SBRT) | Experimental | Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks. Receives: Radiation: Image-Guided Adaptive Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy.
Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion
Measured: Up to 2 years
Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities
Measured: Up to 2 years
Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system
Measured: Up to 2 years
Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system
Measured: Up to 2 years
Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI
Measured: Up to 2 tears
Secondary outcomes (6)
Collection of biomarkers that may be associated with an immunologic systemic response to SBRT
Measured: Up to 2 years
DSS
Measured: Up to 2 years
Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0
Measured: Up to 2 years
Infield tumor LC
Measured: Up to 2 years
OS
Measured: Up to 2 years
Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start3 Jun 2015
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Ann Raldow, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683200
- Sponsor's protocol ID
- 15-000362
- Other IDs
- NCI-2015-01665
- Status last verified
- Mar 2022
- First submitted
- 9 Oct 2015
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System
- ClinicalTrials.gov ID
- NCT02683200
- Acronym / sponsor ID
- 15-000362
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Feb 2016 (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.
This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).
II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions.
SECONDARY OBJECTIVES:
- To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).
II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.
OUTLINE:
Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.
After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (MRI-guided Tri-60Co teletherapy SBRT) | Experimental | Radiation: Image-Guided Adaptive Radiation Therapy, Radiation: Stereotactic Body Radiation TherapyPatients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
- Karnofsky performance status (KPS) >= 70
- No active infections requiring systemic antibiotics
- If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
- Ability to understand and willingness to sign a written informed consent
Key exclusion criteria (4 listed)
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
- Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator
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 |
|---|---|---|
| Image-Guided Adaptive Radiation TherapyAlso: IGARTUndergo MRI-guided Tri-60Co teletherapy SBRT | Radiation | Treatment (MRI-guided Tri-60Co teletherapy SBRT) |
| Stereotactic Body Radiation TherapyAlso: SBRTUndergo MRI-guided Tri-60Co teletherapy SBRT | Radiation | Treatment (MRI-guided Tri-60Co teletherapy SBRT) |
Primary outcome
Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy.
Time frame: Up to 2 years
Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion
Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities
Time frame: Up to 2 years
Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system
Time frame: Up to 2 years
Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system
Time frame: Up to 2 years
Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI
Time frame: Up to 2 tears
6 secondary outcomes
Collection of biomarkers that may be associated with an immunologic systemic response to SBRT
Time frame: Up to 2 years
DSS
Time frame: Up to 2 years
Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0
Time frame: Up to 2 years
Infield tumor LC
Time frame: Up to 2 years
OS
Time frame: Up to 2 years
Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Ann Raldow, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Image-Guided Adaptive Radiation Therapy and Stereotactic Body Radiation Therapy in people with Adult Hepatocellular Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by Jonsson Comprehensive 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 5 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 21 Feb 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy. (time frame: Up to 2 years). The study lists 5 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 21 Feb 2023.