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This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial Chemoembolization (TACE) | Active Comparator | Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated. |
|
| TACE+Stereotactic Body Radiotherapy | Experimental | Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial Chemoembolization (TACE) | Procedure | TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate | Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor down staging | Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months | 3 and 6 months |
| Frequency of adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Determination of the number of subjects alive at 3 years following their final study treatment. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Sanabria, MD | Midwestern Reginal Medical Center | Principal Investigator |
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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 |
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|
| TACE+Stereotactic Body Radiotherapy | Radiation | This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors. |
|
Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors
| 6 months |
| Incidence of local tumor progression | Incidence of local progression as demonstrated by radiological imaging (RECIST criteria) | 6 months |
| Number of patients eligibility for liver transplantation | Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation. | 3 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |