This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
10 Gy three times over 10 days
12.5 Gy three times over 10 days
15 Gy three times over 10 days
University of Chicago
Chicago, Illinois, United States
Maximum Tolerated Dose (Phase 1)
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
Time frame: 28 days
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity
Grade 3+ GI late toxicity
Time frame: 12 months after treatment
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale
Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.
Time frame: 12 months after treatment
Number of Patients Eligible for Surgery to Remove Tumor After Treatment
Time frame: 12 months after treatment
Number of Patients With Local Disease Control
Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria
Time frame: 12 months after treatment
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.
The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).
Time frame: 12 months after treatment
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