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This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation therapy | Radiation | A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria | Percent of participants alive and without tumor progression 3 years following treatment. | 3 months |
| Median Survival Without Tumor Progression | Median time until disease progression or death | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Tumor characteristics:
- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.
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| Name | Affiliation | Role |
|---|---|---|
| David A Bush, MD | Loma Linda University Dept. of Radiation Medicine | Principal Investigator |
| Jerry D Slater, MD | Loma Linda University Department of Radiation Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center / James M. Slater Proton Treatment Center | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15508084 | Result | Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033. | |
| 21264826 | Result | Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24. |
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Patients with documented metastatic disease were excluded from this trial.
Patients with a diagnosis of hepatocellular carcinoma were recruited from the hepatology clinic at Loma Linda University Medical Center to participate in this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Beam Therapy | Patients received 63Gy in three weeks with proton beam. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Beam Therapy | Patients received 63Gy in three weeks with proton beam. |
| 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 |
| 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 | 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria | Percent of participants alive and without tumor progression 3 years following treatment. | Participants that were within the Milan criteria | Posted | Number | percentage of participants | 3 months |
|
|
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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 | Proton Beam Therapy | Patients received 63Gy in three weeks with proton beam. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bush MD | Radiation Medicine - Loma Linda University Medical Center | 909-558-4280 | dbush@dominion.llumc.edu |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Median Survival Without Tumor Progression | Median time until disease progression or death | All participants | Posted | Median | 95% Confidence Interval | months | 3 months |
|
|
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| 5 |
| 76 |
| 0 |
| 76 |
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |