A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for locally advanced and borderline resectable pancreatic cancer. The goal of this study is to evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely delivered and enhance efficacy of tumor directed radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Washington University School of Medicine
St Louis, Missouri, United States
Maximum tolerated dose (MTD)
For the toxicity endpoint purposes of this trial, the patient will be followed from start of treatment until the patient completes 60 days of follow-up from the start of radiation therapy, has a dose-limiting toxicity (DLT), or is lost to follow-up.
Time frame: Completion of toxicity follow-up for all patients (up to 32 months)
Rate of conversion of patients with locally advanced pancreatic cancer or borderline resectable to resectable
Time frame: 1 year
Local control (Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Local control is absence of tumor progression. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Quality of life as measured by the EORTC QLQ-C30
The EORTC QLQ-C30 questionnaire will be utilized.
Time frame: 3 months after completion of treatment (up to 18 weeks)
Frequency of RT adaptation based on MR guidance
The rate at which a change or adaptation to the patient's plan is made based on significant change in anatomy observed on localization MRI. This is defined as \[#of treatment adaptations required\]/\[total # of RT treatments\]
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Time frame: 3 months after completion of treatment (up to 18 weeks)