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The purpose of this study is to test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity | AEs were reviewed for gastrointestinal toxicity. Toxicities of note include grade 3 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity | AEs were assessed for gastrointestinal toxicity. Toxicities of note include grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Mierzwa, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation Therapy | 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy | 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy |
| 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 | Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity | AEs were reviewed for gastrointestinal toxicity. Toxicities of note include grade 3 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity. | Posted | Count of Participants | Participants | 3 months |
|
|
AEs will be collected up to 12 months after the start of treatment.
The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
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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 Body Radiation Therapy | 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Kharofa, Associate Professor, Department of Radiation Oncology | University of Cincinnati Cancer Center | (513)-584-4073 | kharofjr@ucmail.uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2016 | Dec 2, 2021 | Prot_SAP_000.pdf |
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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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| Local Progression Free Survival | Local tumor progression will be defined as >=20% increased size on CT scan compared to a CT. scan from prior to treatment. Distant progression will be defined as any new tumor found outside of the pancreas or periampullary region on CT scan. Local and/or distant progression will be evaluated by both PET/CT (if available) and CT scan as deemed by treating physician. | 1 year |
| Metastasis Free Survival | 1 year |
| Overall Survival | 1 year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity | AEs were assessed for gastrointestinal toxicity. Toxicities of note include grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Local Progression Free Survival | Local tumor progression will be defined as >=20% increased size on CT scan compared to a CT. scan from prior to treatment. Distant progression will be defined as any new tumor found outside of the pancreas or periampullary region on CT scan. Local and/or distant progression will be evaluated by both PET/CT (if available) and CT scan as deemed by treating physician. | Posted | Count of Participants | Participants | 1 year |
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|
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| Secondary | Metastasis Free Survival | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Overall Survival | Posted | Count of Participants | Participants | 1 year |
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|
|
| 11 |
| 17 |
| 2 |
| 17 |
| 8 |
| 17 |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Weight loss | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |