Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy
delivered using daily adaptive dose planning has been shown in a retrospective study to
result in improved overall survival, relative to patients receiving lower radiation doses, in
patients with locally advanced pancreatic cancer, without increasing the rate of serious
gastrointestinal toxicity.
The goal of the proposed trial is to investigative in a controlled, prospective manner the
robustness of this outcome, and to track quality of life over a 5-year trial period.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Pancreatic, Liver, and Related Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Histologically or cytologically confirmed locally advanced adenocarcinoma of the
pancreas that is considered unresectable or borderline resectable on institutional
standardized criteria of unresectability or medical inoperability. Patients with and
without regional adenopathy are eligible as long as lymph nodes are adjacent to
primary tumor.
2. Greater than or equal to 3 months of systemic chemotherapy
3. At least 18 years of age.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
5. Normal bone marrow and organ function as defined below:
1. Absolute neutrophil count ≥ 500/mcL (microliters)
2. Platelets ≥ 50,000/mcL
3. Hemoglobin ≥ 8.0 g/dL (deciliters)
4. Total bilirubin ≤ 1.5 x IULN
5. Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x
Institutional Upper Limit of Normal (IULN)
6. Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she must inform her treating physician
immediately.
7. Ability to understand and willingness to sign an Institutional Review Board (IRB)
approved written informed consent document (or that of legally authorized
representative, if applicable).
Exclusion Criteria:
1. Distant metastatic disease as assessed by staging positron emission tomography /
computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting
radiation therapy
2. Carbohydrate antigen (CA19.9) > 500 U/ml.
3. Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields.
4. Currently receiving any other investigational agents.
5. Major surgery within 4 weeks prior to first day of treatment.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia.
7. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.
8. Medical/psychological contraindication to magnetic resonance imaging (MRI).