RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer
I. To determine the maximum tolerated dose (MTD) of a radiosurgery boost added to
hypofractionated chemoradiation in patients with borderline resectable or unresectable
I. To determine the effect of a radiosurgery boost added to hypofractionated chemoradiation
on surgical morbidity (specifically, healing of the surgical anastomoses and abdominal
wounds and late hemorrhage from blood vessels in the field) in patients with advanced
borderline resectable (BLR) or unresectable pancreatic cancer.
II. To evaluate the utility of diffusion-weighted magnetic resonance imaging (MRI) as an
assessment of treatment response after chemoradiation followed by radiosurgery.
III. To determine the feasibility of collecting tissue for immunohistochemistry (IHC)
analysis via endoscopic ultrasound or computed tomography (CT)-guided fine needle
IV. To utilize pathologic response rates in dose escalated regions, hypofractionated
regions, and the dose gradient region in between to better characterize the radiobiologic
response of pancreatic cancer to radiation dose escalation.
OUTLINE: This is a dose-escalation study of radiosurgery.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once weekly
and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) 5 days a week in
weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then
receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment
continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Fox Chase Cancer Center
United States: Institutional Review Board
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