Carcinoma, HepatocellularNCT03168152
Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma
A study testing Microwave Ablation (MWA) and Stereotactic Body Radiation Therapy (SBRT) in people with Carcinoma, Hepatocellular, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC). This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Microwave Ablation (MWA) and 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 1 Apr 2022
- 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
- Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is defined as having at least one of the following:
- HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or
- A discrete hepatic tumor(s) as defined by the Barcelona criteria10 for cirrhotic patients, >1 cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI
- Presentation at multidisciplinary liver tumor board to assess eligibility for either SBRT or MWA
- Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse hepatic resection. Patients who are on the organ wait list for (orthotopic liver transplantation) OLT will be considered for this trial as a "bridge" to transplant.
- Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5 cm in diameter or less and the combined diameter of both lesions is 5 cm or less.
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- The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT.
- The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology Group Performance Status is an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death).
- Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, MWA or TACE) and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
- Patients must have:
- Platelets ≥ 50,000/mm3
- Child Pugh class A liver function or class B7 (Appendix II)
- INR (international normalized ratio (for anticoagulant monitoring)) < 1.5
- The patient must have a life expectancy of at least 12 weeks
- The patient must be at least 18 years old
- Patients must sign an IRB approved informed consent form for this purpose indicating that they are aware of the investigational aspects of the treatment and the potential risks. They also must be able to understand and the willing to sign a written informed consent.
Who cannot join
- Patients who have received prior abdominal radiation
- Patients with 3 or more foci of HCC
- Patients whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
- Patients with Child Pugh liver function worse than B7
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma
This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).
This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Microwave Ablation (MWA), Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Ablation (MWA)Radiation
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
Stereotactic Body Radiation Therapy (SBRT)Radiation
SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.
| Study group | Role | What they receive |
|---|---|---|
| MWA | Experimental | MWA will typically be administered in one ablation session during which time up to 2 tumors are treated. Receives: Radiation: Microwave Ablation (MWA) |
| SBRT | Experimental | SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to local tumor progression
The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT. Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression. Tumors falling to group PD (progressive disease) would constitute local control failures. Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded. Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started. Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.
Measured: Patients will be followed up to 2 years
Secondary outcomes (7)
Incidence of gastrointestinal (GI) and hepatobiliary toxicity
The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measured: Patients will be followed up to 2 years
Incidence of liver function worsening
The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.
Measured: Patients will be followed up to 2 years
Change in FACT- Hep questionnaire score
The FACT-Hep questionnaire is used to measure health-related quality of life (HRQoL) in patients with hepatobiliary cancers. They are asked questions about their physical, social, emotional and functional well-being and asked to provide a score between 0 and 4 where 0 represents not at all and 4 represents very much.
Measured: Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
Overall survival time
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at last follow-up will be censored on that date.
Measured: Patients will be followed up to 2 years
Progression free survival time
Progression Free Survival (PFS) is defined as the minimum time to death or any progression.
Measured: Patients will be followed up to 2 years
Metastasis free survival time
Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.
Measured: Patients will be followed up to 2 years
Incidence of intrahepatic failure
Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.
Measured: Patients will be followed 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 posted30 May 2017
- Study start11 May 2017
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Why it stopped: No patients were accrued to the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Owen, M.D., Ph.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168152
- Sponsor's protocol ID
- UMCC 2017.001
- Other IDs
- HUM00124501
- Status last verified
- Jun 2018
- First submitted
- 17 May 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03168152
- Acronym / sponsor ID
- UMCC 2017.001
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were accrued to the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 30 May 2017 (actual)
- 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 is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).
This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWA | Experimental | Radiation: Microwave Ablation (MWA)MWA will typically be administered in one ablation session during which time up to 2 tumors are treated. |
| SBRT | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is defined as having at least one of the following:
- Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse hepatic resection. Patients who are on the organ wait list for (orthotopic liver transplantation) OLT will be considered for this trial as a "bridge" to transplant.
- Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5 cm in diameter or less and the combined diameter of both lesions is 5 cm or less.
- The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT.
- The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology Group Performance Status is an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death).
Key exclusion criteria (4 listed)
- Patients who have received prior abdominal radiation
- Patients with 3 or more foci of HCC
- Patients whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
- Patients with Child Pugh liver function worse than B7
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 |
|---|---|---|
| Microwave Ablation (MWA)MWA will typically be administered in one ablation session during which time up to 2 tumors are treated. | Radiation | MWA |
| Stereotactic Body Radiation Therapy (SBRT)SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor. | Radiation | SBRT |
Primary outcome
Time to local tumor progression
Time frame: Patients will be followed up to 2 years
The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT. Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression. Tumors falling to group PD (progressive disease) would constitute local control failures. Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded. Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started. Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.
7 secondary outcomes
Incidence of gastrointestinal (GI) and hepatobiliary toxicity
Time frame: Patients will be followed up to 2 years
Incidence of liver function worsening
Time frame: Patients will be followed up to 2 years
Change in FACT- Hep questionnaire score
Time frame: Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
Overall survival time
Time frame: Patients will be followed up to 2 years
Progression free survival time
Time frame: Patients will be followed up to 2 years
Metastasis free survival time
Time frame: Patients will be followed up to 2 years
Incidence of intrahepatic failure
Time frame: Patients will be followed up to 2 years
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 25 Jun 2018.
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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.
Dawn Owen, M.D., Ph.D. 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 study testing Microwave Ablation (MWA) and Stereotactic Body Radiation Therapy (SBRT) in people with Carcinoma, Hepatocellular, 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 16 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: withdrawn, as of the sponsor's last update on 25 Jun 2018. 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?
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?
Time to local tumor progression (time frame: Patients will be followed up to 2 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 25 Jun 2018.