| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma HCC | Radiation: Stereotactic Body Radiation Therapy (SBRT) Procedure: Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 196 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma. |
| Actual Study Start Date : | March 1, 2020 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
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Stereotactic Body Radiation Therapy (SBRT)
Radiation Therapy
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Radiation: 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.
Other Name: Radiation Therapy
|
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Trans-Arterial Chemoembolization (TACE)
Procedure/Surgery - Chemoembolization Drug: Doxorubin
|
Procedure: 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
Other Name: Chemoembolization
Drug: Doxorubin This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
Other Name: Doxorubin bead therapy
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
Patients must have adequate organ function within 2 weeks of enrollment.
Exclusion Criteria:
| Contact: Julie Roache | 781-744-3055 | julia.roache@lahey.org |
| United States, Massachusetts | |
| Lahey Hospital & Medical Center | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Li Zhang, MS 781-744-3495 li.zhang@lahey.org | |
| Contact: Victoria Angelucci, RN victoria.angelucci@lahey.org | |
| Principal Investigator: Francis W Nugent, MD | |
| Principal Investigator: | Francis W. Nugent, III, MD | Lahey Hospital & Medical Center |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 30, 2019 | ||||||
| First Posted Date ICMJE | May 22, 2019 | ||||||
| Last Update Posted Date | August 6, 2020 | ||||||
| Actual Study Start Date ICMJE | March 1, 2020 | ||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 1 year post treatment ] | ||||||
| Original Primary Outcome Measures ICMJE |
Time to first additional intervention to the treated lesions [ Time Frame: 1 year post treatment ] | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant | ||||||
| Official Title ICMJE | A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma. | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
196 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 2024 | ||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03960008 | ||||||
| Other Study ID Numbers ICMJE | 20193013 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Lahey Clinic | ||||||
| Study Sponsor ICMJE | Lahey Clinic | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Lahey Clinic | ||||||
| Verification Date | August 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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