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| ID | Type | Description | Link |
|---|---|---|---|
| PANC0005 | Other Identifier | Stanford OnCore |
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This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine
In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Local Control | The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival Time | The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves. | up to 3 years |
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Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Koong | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiotherapy | patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes. Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SBRT | 25 Gy single fraction dose using Trilogy linear accelerator |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Rate of Local Control | The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression. | Posted | Number | participants | up to 3 years |
|
following SBRT, follow-up at 4-6 weeks, then every 3 months in year 1 and 4 months year 2.
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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 | SBRT With Gem | patient with locally advanced pancreas cancer receiving Gem + SBRT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment | duodenal perforation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment | pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Albert Koong | Stanford Cancer Center | 650-498-7703 | akoong@stanford.edu |
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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 |
| D000093542 | Gemcitabine |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Gemcitabine | Drug | Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes |
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| 4D pancreatic protocol CT scan | Other | Patients will undergo this imaging procedure prior to treatment for planning purposes. |
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| FDG PET scan | Radiation | Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning. |
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| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Median Overall Survival Time | The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves. | Posted | Median | Full Range | months | up to 3 years |
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| 1 |
| 20 |
| 6 |
| 20 |
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| vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| ulcer | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |