Combination Chemotherapy, Intensity-Modulated Radiation Therapy, and Surgery in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery

• Median overall survival of patients with adenocarcinoma of the pancreas [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 22 months ] [ Designated as safety issue: No ]
  Estimated by the Kaplan Meier method.
  
  

• Percent of patients surviving [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  
• Median recurrence free survival following pancreaticoduodenectomy [ Time Frame: From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years ] [ Designated as safety issue: No ]
  The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
  
  
• Clinical response rate to neoadjuvant chemotherapy and chemoradiotherapy [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
  
  
• Pathologic response rate to neoadjuvant chemotherapy and chemoradiotherapy [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM).
  
  
• CA 19-9 tumor marker response rate to neoadjuvant chemotherapy and chemoradiotherapy [ Time Frame: Baseline and day 1 of each course, up to 26 weeks after surgery ] [ Designated as safety issue: No ]
  Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
  
  
• Surgical completion rate and complication rate [ Time Frame: Up to 6 weeks following the completion of chemoradiotherapy ] [ Designated as safety issue: No ]
  
• Frequency and severity of toxicities associated with this treatment regimen as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 26 weeks after surgery (the end of adjuvant chemotherapy) ] [ Designated as safety issue: Yes ]
  

PRIMARY OBJECTIVES:

I. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the percent of patients surviving at annual intervals through five years.

II. To determine the median recurrence free survival following pancreaticoduodenectomy.

III. To determine the clinical response rate to neoadjuvant chemotherapy and chemoradiotherapy.

IV. To determine the pathologic response rate to neoadjuvant chemotherapy and chemoradiotherapy.

V. To determine the cancer antigen (CA) 19-9 tumor marker response rate to neoadjuvant chemotherapy and chemoradiotherapy.

VI. To determine the surgical completion rate and complication rate following neoadjuvant chemotherapy and chemoradiotherapy.

VII. To determine the frequency and severity of toxicities associated with this treatment regimen.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 75 minutes and docetaxel IV over 30 or 60 minutes on days 4 and 11. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

NEOADJUVANT CHEMORADIOTHERAPY: Beginning no more than 14 days after completion of induction chemotherapy, patients receive capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo IMRT once daily on days 1-5 and 8-13.

SURGICAL RESECTION: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy.

ADJUVANT CHEMOTHERAPY: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.