Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
NCT ID: NCT02454140
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-06-20
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort 1
SBRT 40 Gy in 5 fractions
SBRT
Fixed five-fraction stereotactic radiotherapy
Cohort 2
SBRT 45 Gy in 5 fractions (starting dose level)
SBRT
Fixed five-fraction stereotactic radiotherapy
Cohort 3
SBRT 50 Gy in 5 fractions
SBRT
Fixed five-fraction stereotactic radiotherapy
Cohort 4
SBRT 55 Gy in 5 fractions
SBRT
Fixed five-fraction stereotactic radiotherapy
Cohort 5
SBRT 60 Gy in 5 fractions
SBRT
Fixed five-fraction stereotactic radiotherapy
Interventions
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SBRT
Fixed five-fraction stereotactic radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
* Tumor Location: Primary tumor may be located anywhere in the pancreas.
* Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
* Performance Level: Karnofsky Performance Status ≥ 60
* Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
* Informed Consent: All subjects must sign a written informed consent.
Exclusion Criteria
* Life expectancy \< 6 months
* The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
* Incarcerated individuals
* Subjects unable to give informed consent
18 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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James D. Murphy, MD, MS
Associate Clinical Professor, Radiation Medicine
Principal Investigators
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James D Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UCSD Moores Cancer Center
La Jolla, California, 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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140103
Identifier Type: -
Identifier Source: org_study_id
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