This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Type and the severity of side effects
Time frame: 5 years
Number of surviving patients at 1 year after treatment
Time frame: 1 year
Number of patients who disease has not progressed
Time frame: 2 years
Number of patients that are able to receive surgery after chemoradiation
Time frame: 5 years
Average length of hospital stay per patient
Time frame: 5 years
Number of surviving patients at 30-days after surgery
Time frame: 30 days after surgery
Number of surviving patients at 90-days after surgery
Time frame: 90 days after surgery
Number of patients who need to be re-admitted to the hospital at 90-days after surgery
Time frame: 90 days after surgery
Time to Progression
Time frame: 5 years
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