Pancreas Cancer Clinical Trial
Official title:
A Single Center Pilot Study: Neoadjuvant Modified FOLFIRINOX or Gemcitabine-nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer and Borderline Pancreatic Inoperable Cancers
The purpose of this study is to evaluate a new treatment routine for patients with borderline resectable and unresectable pancreas cancers.
We want to find out what effects, good and bad, using chemotherapy combinations modified
FOLFIRINOX (Oxaliplatin, Irinotecan, and fluorouracil) OR gemcitabine plus nab-paclitaxel
(Gem-ABRAXANE) and radiation using Stereotactic Body Radiation Therapy (SBRT) have on the
cancer and to increase the percentage of patients who can have surgery to remove their
disease. SBRT is a short course of high dose precisely delivered radiation. The two
combination chemotherapy routines (mFOLFIRINOX or GEM-ABRAXANE) have been shown in previous
clinical trials to be the most effective FDA approved chemotherapy in wide spread pancreatic
cancers. These chemotherapy drugs will be given before the surgery. Radiation Therapy, using
the 5 ½ week method as well as SBRT has been used as standard of care and found to be
effective to reduce the size of pancreatic cancer, so patients can have surgery.
SBRT uses advance techniques to deliver radiation therapy which minimizes the volume of
normal tissue receiving high dose radiation while maximizing the dose to the tumor. The use
of SBRT spares normal tissue and reduces the side effects of radiation. By being more
precise, and using a higher dose of radiation per treatment, the radiation delivery time can
be decreased to about one week. When this chemotherapy followed by SBRT is combined in this
order, this routine has the potential to treat both the primary disease, as well as to
prevent the early spread of disease. It is hoped that the treatment routines in this study
will increase the percentage of patients who can proceed to have surgery to remove their
tumor.
This combination of chemotherapy drugs, mFOLFIRINOX or GEM-ABRAXANE and the sequence of
chemotherapy followed by SBRT- the shorter course of radiation has not been studied
previously and is considered investigational.
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