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This study was closed early due to lack of enrollments and insufficient funding.
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
| Merit Medical Systems, Inc. | INDUSTRY |
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This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Other | Radiation Therapy |
|
| Trans-Arterial Chemoembolization (TACE) | Other | Procedure/Surgery - Chemoembolization Drug: Doxorubin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days. |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation | To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment. | 1 year post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | To compare treatment related adverse events between both arms, SBRT and TACE. | At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment |
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Inclusion Criteria:
Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
Subjects must be eligible per standard of care for either TACE or SBRT procedures.
Subjects must have a life expectancy of at least 12 weeks.
Subjects must be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.
Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .
Subjects must have a Child-Turcotte-Pugh (CTP) score ≤8.
Patients must have adequate organ function within 2 weeks of enrollment.
Patients uninvolved liver volume will be estimated and must be > 700ml.
Patients must have a Zubrod performance status of ≤2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrine Zarwan, MD | Lahey Hospital & Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation Therapy (SBRT) | Radiation Therapy Stereotactic Body Radiation Therapy (SBRT): SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days. |
| FG001 | Trans-Arterial Chemoembolization (TACE) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2021 |
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|
| Trans-Arterial Chemoembolization (TACE) | Procedure | First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation |
|
|
| Doxorubin | Drug | This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. |
|
|
| Number of Further Interventions |
To compare the number of further interventions between the SBRT and TACE arms. |
| 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment |
| Rate of Pathological Response of Treated Lesion(s) | Complete pathologic response of lesions will be analyzed on the explant liver specimen after liver transplant. The pathology note will be consulted. | Review of pathology report after liver transplant |
| Rate of Radiological Response of Treated Lesion(s) | Response of treated lesions will be analyzed at protocol specified time frames. The response rate between both treatment arms will be compared. | Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment |
| To Assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire | A 45-item self-report instrument to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers and is one of the most widely-used instruments in this clinical area. The FACT-Hep consists of the 27-item FACT-G, assesses HRQL, and the 18-item Hepatobiliary Subscale (HS), assesses disease-specific issues such as pain, appetite, and cramping. The FACT-G evaluates physical well-being, social/family well-being, emotional well-being, and functional well-being. Sections have a 7-day reference period and are scored from 0-4 ("not at all" to "very much"), with higher scores indicating better HRQL. Score ranges are 0-28 for physical well-being, 0-28 for social/family well-being, 0-24 for emotional well-being, 0-28 for functional well-being, and 0-72 for the HS. All subscale scores from the FACT-G and HS can be summed together to create a total FACT-Hep score, with a possible range of 0-180. The FACT-Hep takes approximately 10 minutes to complete. | Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment |
| To Assess Over Survival | Overall survival will be compared in both arms at protocol specified time frames. | Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment |
| To Assess 90 Day Post-transplant Morbidity | Compare the morbidity at 90 days post transplant between both arms. | Disease status to be captured 90 days post-transplantation (+/- 2 weeks) |
| To Assess 90 Day Post-transplant Mortality | Will assess the mortality of post-transplant patients between the two arms. | Survival status to be captured 90 days post-transplantation (+/- 2 weeks) |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43202 | United States |
| Princess Margaret Hospital, UHN | Toronto | Ontario | M5G 1X6 | Canada |
Procedure/Surgery - Chemoembolization Drug: Doxorubin Trans-Arterial Chemoembolization (TACE): First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy (SBRT) | Radiation Therapy Stereotactic Body Radiation Therapy (SBRT): SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days. |
| BG001 | Trans-Arterial Chemoembolization (TACE) | Procedure/Surgery - Chemoembolization Drug: Doxorubin Trans-Arterial Chemoembolization (TACE): First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation | To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment. | Data has not been collected and therefore not analyzed for this outcome. | Posted | 1 year post treatment |
|
| ||||||||||||||||||||||
| Secondary | To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | To compare treatment related adverse events between both arms, SBRT and TACE. | Data has not been collected and therefore not analyzed for this outcome | Posted | At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment |
|
| ||||||||||||||||||||||
| Secondary | Number of Further Interventions | To compare the number of further interventions between the SBRT and TACE arms. | Data has not been collected and therefore not analyzed for this outcome. | Posted | 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment |
|
| ||||||||||||||||||||||
| Secondary | Rate of Pathological Response of Treated Lesion(s) | Complete pathologic response of lesions will be analyzed on the explant liver specimen after liver transplant. The pathology note will be consulted. | Data has not been collected and therefore not analyzed for this outcome. | Posted | Review of pathology report after liver transplant |
|
| ||||||||||||||||||||||
| Secondary | Rate of Radiological Response of Treated Lesion(s) | Response of treated lesions will be analyzed at protocol specified time frames. The response rate between both treatment arms will be compared. | Data has not been collected and therefore not analyzed for this outcome | Posted | Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment |
|
| ||||||||||||||||||||||
| Secondary | To Assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire | A 45-item self-report instrument to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers and is one of the most widely-used instruments in this clinical area. The FACT-Hep consists of the 27-item FACT-G, assesses HRQL, and the 18-item Hepatobiliary Subscale (HS), assesses disease-specific issues such as pain, appetite, and cramping. The FACT-G evaluates physical well-being, social/family well-being, emotional well-being, and functional well-being. Sections have a 7-day reference period and are scored from 0-4 ("not at all" to "very much"), with higher scores indicating better HRQL. Score ranges are 0-28 for physical well-being, 0-28 for social/family well-being, 0-24 for emotional well-being, 0-28 for functional well-being, and 0-72 for the HS. All subscale scores from the FACT-G and HS can be summed together to create a total FACT-Hep score, with a possible range of 0-180. The FACT-Hep takes approximately 10 minutes to complete. | Data has not been collected and therefore not analyzed for this outcome. | Posted | Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment |
| |||||||||||||||||||||||
| Secondary | To Assess Over Survival | Overall survival will be compared in both arms at protocol specified time frames. | Data has not been collected and therefore not analyzed for this outcome | Posted | Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment |
|
| ||||||||||||||||||||||
| Secondary | To Assess 90 Day Post-transplant Morbidity | Compare the morbidity at 90 days post transplant between both arms. | Data has not been collected and therefore not analyzed for this outcome | Posted | Disease status to be captured 90 days post-transplantation (+/- 2 weeks) |
|
| ||||||||||||||||||||||
| Secondary | To Assess 90 Day Post-transplant Mortality | Will assess the mortality of post-transplant patients between the two arms. | Data has not been collected and therefore not analyzed for this outcome. | Posted | Survival status to be captured 90 days post-transplantation (+/- 2 weeks) |
|
|
Baseline, During Treatment, post treatment follow-up visit, 3 Month, 6 Month, then every 3 months until 24 month time point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Body Radiation Therapy (SBRT) | Radiation Therapy Stereotactic Body Radiation Therapy (SBRT): SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Trans-Arterial Chemoembolization (TACE) | Procedure/Surgery - Chemoembolization Drug: Doxorubin Trans-Arterial Chemoembolization (TACE): First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. | 0 | 5 | 0 | 5 | 0 | 5 |
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This study closed to accrual early, with the limited number of participants, we were unable to analyze the data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Roache, Manger, Research Programs | Lahey Hospital & Medical Center | 7817443055 | julia.roache@lahey.org |
| May 10, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D011878 | Radiotherapy |
| D016461 | Chemoembolization, Therapeutic |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D060205 | Therapeutic Occlusion |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Participants |
|
|
| Participants |
|
| Participants |
|
| Trans-Arterial Chemoembolization (TACE) |
Procedure/Surgery - Chemoembolization Drug: Doxorubin Trans-Arterial Chemoembolization (TACE): First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. |
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