Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body
NCT ID: NCT02208024
Last Updated: 2022-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2014-08-27
2019-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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Stereotactic Body Radiation Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
* Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
* No active infection requiring hospitalization
* Adequate labs
* Life expectancy \> 3 months.
* Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.
Exclusion Criteria
* Infections requiring systemic antibiotic treatment.
19 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Jordan Kharofa
Assistant Professor Radiation Oncology
Principal Investigators
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Michelle Mierzwa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UCCI-GI-002
Identifier Type: -
Identifier Source: org_study_id
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