Liver NeoplasmsPhase 1NCT01862718
Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
A Phase 1 study testing Thermal Ablation and Standard External Beam Radiation Therapy in people with Liver Neoplasms and Hepatic Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation). Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Hepatic Cancer, Liver Cancer
- What is being tested?
- Thermal Ablation and Standard External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2013to 5 Nov 2019
- Phase
- 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 with hepatic-dominant neoplasms where the life limiting component of the disease is hepatic neoplasms
- Patients hepatic lesions must be considered technically unresectable or that their overall health makes surgery inadvisable
- Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter
- Patients with extrahepatic neoplasms or an unresected primary lesion will be considered eligible if the extrahepatic disease is minimal and stable
- Serum Creatinine less than or equal to 2.0 mg/dl unless the measured creatinine clearance is greater than 60 ml/min.
- Absolute neutrophil count (ANC) greater than or equal to1500/m3 without help of Filgastim, hemoglobin greater than 8 g/dL, and platelet count greater than or equal to 75,000 m3
Show all 17Show fewer
- Bilirubin less than 3 mg/dl, and AST and ALT less than 5 X upper limit of normal except in the presence of obstructive liver neoplasms where ALT/AST may be up to 10 X the upper limit of normal.
- Prothrombin Time (PT) within 2 seconds of the upper limit normal (INR less than or equal to 1.5)
- Patient on oral, SQ or IV anticoagulants will be expected to have an abnormal PT and will be considered eligible if they can safely dicontinue the anticoagulant before ablation. A repeat PT will be obtained at least 24 hours prior to the radiofrequency ablation (only) and should be within practice safety guidelines of an INR less than 1.5 or if greater than 1.5 have clinical reversal agent as appropriate to the anticoagulant administered.
- Extent of hepatic neoplasms is approximately less than 60% of total hepatic volume
- Patients must have pathology proof of neoplasm. If proof of pathology is unavailable, histopathological confirmation of liver neoplasm may not be requisite in the setting of clinical or radiological characteristics that are highly suggestive of a neoplastic diagnosis, with such designation determined by PI and a medical or surgical oncologist, with the NCI multidisciplinary gastrointestinal tumor board review, in the event of absence of such consensus.
- Patients referred for ablation or radiation of liver neoplasm
- ECOG performance status less than or equal to 2
- Life expectancy greater than 3 months
- At least 18 years of age
- Age less than 85 years
- Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for at least 28 days prior to treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions.
Who cannot join
- Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the liver
- Prior biliary diversion surgery
- Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy.
- Any exclusion criteria for radiation or for ablation, such as ataxia telangiectasia, active connective tissue disease, or inflammatory bowel disease, or other known conditions which predispose to radiation toxicities
- Patients with an acute, critical illness
- Pregnant women are excluded from the study. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Read more
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness
If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded)
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Read the detailed description
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic neoplasms represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy to liver, or biological therapy must have had last dose/ treatment for at least 14 days prior to starting study treatments.
Patients must not have an acute, critical illness
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
- Conditions
- Liver Neoplasms, Hepatic Cancer, Liver Cancer
- Being tested
- Thermal Ablation, Standard External Beam Radiation Therapy
- Keywords
- Fusion, Tracking, Ablation, Hepatic Neoplasms
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal AblationProcedure or surgery
On Thursday in the first week, subject will receive the radiofrequency ablation.
Standard External Beam Radiation TherapyProcedure or surgery
During those 2 weeks, subject will receive radiation on Monday, Wednesday and Friday.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ablation plus radiation Receives: Procedure: Thermal Ablation; Procedure: Standard External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Ablation plus radiation
Descriptive statistics will be provided in summary tables. When relevant, the 95% confidence intervals (CI) will also be displayed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start19 Nov 2013
- Primary completion2 Nov 2017
- Study completion5 Nov 2019
Why it stopped: Slow/Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bradford J Wood, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862718
- Sponsor's protocol ID
- 130079
- Other IDs
- 13-CC-0079
- Status last verified
- Aug 2022
- First submitted
- 23 May 2013
- Last updated
- 15 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .It is not yet known if there will be a plan to make IPD available
Publications
Komorizono Y, Oketani M, Sako K, Yamasaki N, Shibatou T, Maeda M, Kohara K, Shigenobu S, Ishibashi K, Arima T. Risk factors for local recurrence of small hepatocellular carcinoma tumors after a single session, single application of percutaneous radiofrequency ablation. Cancer. 2003 Mar 1;97(5):1253-62. doi: 10.1002/cncr.11168.
PubMed 12599233Siperstein AE, Rogers SJ, Hansen PD, Gitomirsky A. Laparoscopic thermal ablation of hepatic neuroendocrine tumor metastases. Surgery. 1997 Dec;122(6):1147-54; discussion 1154-5. doi: 10.1016/s0039-6060(97)90221-x.
PubMed 9426432Buscarini L, Rossi S, Fornari F, Di Stasi M, Buscarini E. Laparoscopic ablation of liver adenoma by radiofrequency electrocauthery. Gastrointest Endosc. 1995 Jan;41(1):68-70. doi: 10.1016/s0016-5107(95)70279-2. No abstract available.
PubMed 7698628
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
- ClinicalTrials.gov ID
- NCT01862718
- Acronym / sponsor ID
- 130079
- Conditions
- Liver Neoplasms, Hepatic Cancer, Liver Cancer
- Keywords
- Fusion, Tracking, Ablation, Hepatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow/Insufficient accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 19 Nov 2013 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 24 May 2013 (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.
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness
If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded)
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Detailed description
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic neoplasms represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy to liver, or biological therapy must have had last dose/ treatment for at least 14 days prior to starting study treatments.
Patients must not have an acute, critical illness
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Thermal Ablation, Procedure: Standard External Beam Radiation TherapyAblation plus radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with hepatic-dominant neoplasms where the life limiting component of the disease is hepatic neoplasms
- Patients hepatic lesions must be considered technically unresectable or that their overall health makes surgery inadvisable
- Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter
- Patients with extrahepatic neoplasms or an unresected primary lesion will be considered eligible if the extrahepatic disease is minimal and stable
- Serum Creatinine less than or equal to 2.0 mg/dl unless the measured creatinine clearance is greater than 60 ml/min.
Key exclusion criteria (6 listed)
- Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the liver
- Prior biliary diversion surgery
- Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy.
- Any exclusion criteria for radiation or for ablation, such as ataxia telangiectasia, active connective tissue disease, or inflammatory bowel disease, or other known conditions which predispose to radiation toxicities
- Patients with an acute, critical illness
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 |
|---|---|---|
| Thermal AblationOn Thursday in the first week, subject will receive the radiofrequency ablation. | Procedure or surgery | 1 |
| Standard External Beam Radiation TherapyDuring those 2 weeks, subject will receive radiation on Monday, Wednesday and Friday. | Procedure or surgery | 1 |
Primary outcome
Safety of Ablation plus radiation
Time frame: 3 years
Descriptive statistics will be provided in summary tables. When relevant, the 95% confidence intervals (CI) will also be displayed.
Results and safety
The study was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 12599233Komorizono Y, Oketani M, Sako K, Yamasaki N, Shibatou T, Maeda M, Kohara K, Shigenobu S, Ishibashi K, Arima T. Risk factors for local recurrence of small hepatocellular carcinoma tumors after a single session, single application of percutaneous radiofrequency ablation. Cancer. 2003 Mar 1;97(5):1253-62. doi: 10.1002/cncr.11168.
- Background: PubMed 9426432Siperstein AE, Rogers SJ, Hansen PD, Gitomirsky A. Laparoscopic thermal ablation of hepatic neuroendocrine tumor metastases. Surgery. 1997 Dec;122(6):1147-54; discussion 1154-5. doi: 10.1016/s0039-6060(97)90221-x.
- Background: PubMed 7698628Buscarini L, Rossi S, Fornari F, Di Stasi M, Buscarini E. Laparoscopic ablation of liver adenoma by radiofrequency electrocauthery. Gastrointest Endosc. 1995 Jan;41(1):68-70. doi: 10.1016/s0016-5107(95)70279-2. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .It is not yet known if there will be a plan to make IPD available
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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.
Bradford J Wood, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thermal Ablation and Standard External Beam Radiation Therapy in people with Liver Neoplasms and Hepatic Cancer, run by National Institutes of Health Clinical Center (CC) 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 17 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: stopped early, as of the sponsor's last update on 15 Aug 2022. 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 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.
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 was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
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?
Safety of Ablation plus radiation (time frame: 3 years). 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 NCT01862718, which also lists 3 linked publications.
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 15 Aug 2022.