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Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial Chemoembolization | Active Comparator | Transarterial Chemoembolization |
|
| Proton Beam Radiotherapy | Active Comparator | Proton Beam Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial Chemoembolization | Procedure | Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two Year Overall Survival | Comparison between arms of the percentage of patient alive 2 years following study treatment. | 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael deVera, MD | Loma Linda University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transarterial Chemoembolization | Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. |
| FG001 | Proton Beam Radiotherapy | Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transarterial Chemoembolization | Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. |
| BG001 | Proton Beam Radiotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Two Year Overall Survival | Comparison between arms of the percentage of patient alive 2 years following study treatment. | Eligible subjects were adult patients with newly diagnosed and previously untreated HCC. All subjects had characteristic findings of HCC on contrast-enhanced magnetic resonance imaging (MRI) and/or computed tomography (CT) scanning or histologic proof with biopsy. Patients were required to have tumors that were within the Milan or San Francisco criteria, although eligibility for transplant was not required. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 Months |
|
30 months
74 participants at risk
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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 | Transarterial Chemoembolization | Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver Failure | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bush, MD, Professor Radiation Medicine | Loma Linda University Health | 909 558 1000 | 88056 | DBush@llu.edu |
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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 | Mar 5, 2009 | Aug 3, 2023 | Prot_SAP_000.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 |
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| ID | Term |
|---|---|
| D002741 | Chlorotrianisene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
| Proton Beam Radiotherapy | Radiation | Fifteen consecutive sessions |
|
Proton Beam Radiotherapy
Proton Beam Radiotherapy: Fifteen consecutive sessions
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Proton Beam Radiotherapy |
Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions |
|
|
| 13 |
| 39 |
| 8 |
| 39 |
| 39 |
| 39 |
| EG001 | Proton Beam Radiotherapy | Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions | 16 | 35 | 2 | 35 | 35 | 35 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| GI Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |