Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer
Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer
The purpose of this research study is to determine if it is possible to deliver high dose
 radiation in one week while also giving the drug capecitabine for the treatment of pancreatic
 cancer prior to surgery, to determine if this treatment can be given safely for the treatment
 of pancreatic cancer prior to surgery and, to determine if this treatment can improve the
 local control pancreatic cancer prior to surgery compared to historical controls of standard
 treatment.
OBJECTIVES:

 Primary

 -  Phase I: To determine the feasibility and tolerability of radiation therapy for
 pancreatic cancer delivered with high dose external beam radiation in a one week
 accelerated schedule with concurrent capecitabine

 -  Phase II: To demonstrate a grade 3 or greater (any) toxicity rate of less than 20%

 Secondary

 -  To determine local control and recurrence patterns of pancreatic cancer relative to a
 standard regimen of 50.4 Gy as seen in historical controls

 -  To determine the pathologic response rate

 -  To determine the progression-free survival

 -  To determine the surgical morbidity

 -  To determine 30-day post-operative mortality after pancreatic resection
Inclusion Criteria:

 -  Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to
 treatment.

 -  No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan
 (or MRI with gadolinium and/or manganese), and all patients must be staged with a
 physical exam, chest CT, and abdominal CT with intravenous contrast.

 -  Only potentially resectable patients are eligible. Potentially resectable is defined
 as: a)no extrapancreatic disease, b)no evidence (on CT) of involvement of the celiac
 axis or superior mesenteric artery, and c)no evidence (on CT or MRI) of occlusion of
 the superior mesenteric vein or superior mesenteric-portal venous confluence.

 -  18 years of age or older

 -  ECOG Performance status of 0 or 1

 -  Women of child bearing potential must practice adequate contraception and to refrain
 from breast feeding. Female patients must have a negative pregnancy test within 7 days
 of treatment

 -  Lab values as specified in the protocol

 Exclusion Criteria:

 -  Patients cannot have hepatic or peritoneal metastases detected by imaging or
 laparoscopy prior to chemoradiation

 -  Serious concomitant systemic disorders incompatible with the study, such as
 significant cardiac or pulmonary morbidity, or ongoing infection as manifested by
 fever

 -  Pregnant or lactating women

 -  Life expectancy < 3 months

 -  Serious, uncontrolled, concurrent infection(s)

 -  Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor

 -  Treatment for other cancers within the last five years, except cured non-melanoma skin
 cancer and treated in situ cervical cancer

 -  Clinically significant cardiac disease or myocardial infarction within the last 12
 months

 -  Other serious uncontrolled medical conditions that the investigator feels might
 compromise study participation

 -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
 syndrome

 -  Known, existing uncontrolled coagulopathy

 -  Unwillingness to participate or inability to comply with the protocol for the duration
 of the study

 -  Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed
 at least 6 months earlier)

 -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known
 hypersensitivity to 5-fluorouracil or known DPD deficiency

 -  Participation in any investigational drug study within 4 weeks preceding the start of
 study treatment

 -  History of uncontrolled seizures, central nervous system disorders or psychiatric
 disability judged by the investigator to be clinically significant, precluding
 informed consent, or interfering with compliance or oral drug intake

 -  Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,
 without complete recovery

 -  Patients should not be on cimetidine as it can decrease the clearance of 5-FU. Another
 H2-blocker or proton pump inhibitor may be substituted before study entry