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Phase I Dual Dose Escalation Trial of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

Summary

The phase I portion of the study (sub-trial 1) will use nab-paclitaxel in escalating doses while the radiation dose is held constant at a standardly accepted level. Following determination of the maximum tolerated dose of nab-paclitaxel, the second part of this study (sub-trial 2), will include nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization and will be treated at breath hold in order to prevent tumor movement with normal respiration. Correlative tissue and serum biomarkers are an optional part of this study.

General Information

NCT#: NCT02207465
Study ID: UPCC 32213
Trial Phase: Phase I

Trial Sponsor: University of Pennsylvania Abramson Cancer Center
Therapies Used in This Trial: Nab-paclitaxel, Gemcitabine, Intensity modulated radiation therapy (IMRT), Proton Radiation

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