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This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liver metastases | Other | Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes |
|
| Primary Liver Tumors | Other | Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiosurgery | Radiation | 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Recurrence Rate | Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Late Complication Rates | Toxicities will be assessed using CTCAE grading criteria at specified timepoints. | 5 years |
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Inclusion Criteria:
Total bilirubin < 3 mg/dL Serum albumin > 2.5 g/dL Serum levels of liver enzymes < 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication
- Signed study-specific consent form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany G Sleckman, MD | Mercy Hospital St. Louis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Metastases | Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) |
| FG001 | Primary Liver Tumors | Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No patients were analyzed in primary liver tumors because none were enrolled to that group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Metastases | Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) |
| BG001 |
| 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 | Local Tumor Recurrence Rate | Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume. | No patients enrolled into primary liver tumor group. | Posted | Count of Participants | Participants | 5 years |
|
5 years
At risk for primary liver tumor is 0 because no patients were enrolled to this group.
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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 | Liver Metastases | Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle McFarland, MPH, CHRC | Mercy Research | 314-251-8827 | michelle.mcfarland@mercy.net |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic Body Radiotherapy | Radiation | 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) |
|
| Primary Liver Tumors |
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Late Complication Rates | Toxicities will be assessed using CTCAE grading criteria at specified timepoints. | This outcome was not collected. | Posted | 5 years |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Primary Liver Tumors | Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |