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due to low enrollment
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This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Beam Radiotherapy plus Sorafenib | Active Comparator | A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. |
|
| Sorafenib | Active Comparator | Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiotherapy | Radiation | Fifteen consecutive sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate Between Time of Consent and Time of Death | All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months. | Change between time of informed consent and primary completion date of study, an average of 4 years per participant |
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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 | Proton Beam Radiotherapy Plus Sorafenib | A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid |
| FG001 | Sorafenib | Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Beam Radiotherapy Plus Sorafenib | A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid |
| BG001 | Sorafenib |
| 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 | Overall Survival Rate Between Time of Consent and Time of Death | All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months. | two subjects withdrew prior to over all survival rate measurement | Posted | Mean | Full Range | years | Change between time of informed consent and primary completion date of study, an average of 4 years per participant |
|
Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up
All subjects are at risk for serious and non serious adverse events due to the progression of their liver disease and the possible side effects from both study treatment arms.
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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 Radiotherapy Plus Sorafenib | A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death - cerebral hemorrahic stroke | General disorders | Systematic Assessment | Subject randomized to Arm "A" - received 5 proton treatments starting 11/2010 to 12/2010, had a cerebral hemorrhage 5/2014 and expired. This incident was rated as possibly related to treatment yet expected in this population. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Scavone, research coordinator | Loma Linda University Medical Center | 909 558-3636 | 33670 | dscavone@llu.edu |
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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 |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sorafenib | Drug | 400 mg po bid |
|
Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alfa-feto protein | Reference range for 0 - 100 years -All 0 - 8.7 ng/ml Baseline alpha feto protein levels were measured not to serve as a measure of eligibility or outcomes, but simply as another marker for the diagnosis of hepatocellular carcinoma. | 8 subjects were consented. 4 to Arm A, and 4 to Arm B. However, 2 subjects (one from each arm) withdrew consent or were lost to follow up leaving 6 subjects total to be analyzed. | Mean | Standard Deviation | ng/ml |
|
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid |
| OG001 | Sorafenib | Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid |
|
|
| 3 |
| 4 |
| 1 |
| 4 |
| 0 |
| 4 |
| EG001 | Sorafenib | Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid | 3 | 4 | 0 | 4 | 0 | 4 |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|