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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02945 | Registry Identifier | NCI CTRP |
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Low accrual rate
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The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomotherapy | Experimental | Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomotherapy treatment | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate (Complete Response + Partial Response). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Liem, MD | University of New Mexico Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
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| Label | URL |
|---|---|
| University of New Mexico Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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8 subjects were screened; 6 did not meet entry criteria. 2 subjects were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Tomotherapy | Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV. Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tomotherapy | Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV. Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Tumor Response Rate (Complete Response + Partial Response). | Study was terminated due to low accrual; no results to report | Posted | 1 year |
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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 | Tomotherapy | Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV. Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Liem, MD | University of New Mexico | 505-272-0086 | bliem@salud.unm.edu |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects. | Study was terminated due to low accrual; no results to report. | Posted | 1 year |
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| 0 |
| 2 |
| 0 |
| 2 |
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| D008107 |
| Liver Diseases |