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This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.
This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Stereotactic Radiation to Pancreas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity Rate | Toxicities will be graded using CTCAE criteria at specified timepoints. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Stereotactic Radiation to Pancreas | Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiation to Pancreas | Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Local Control Rate | Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence. | Posted | Count of Participants | Participants | 5 years |
|
|
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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 | Stereotactic Radiation to Pancreas | Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kathy Baglan | Mercy | 3144345886 | kathy.baglan@mercy.net |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Late Toxicity Rate | Toxicities will be graded using CTCAE criteria at specified timepoints. | This outcome was not collected as planned. | Posted | 5 years |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |