This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Given IV
Given PO
Undergo IMRT
Given IV
Undergo pancreaticoduodenectomy
Undergo therapeutic conventional surgery
Correlative studies
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Time at which Kaplan-Meier estimate of overall survival drops below 50%
Time frame: 5 years
Percent of Patients Surviving at 5 Years
Kaplan-Meier estimate of overall survival at 5 years
Time frame: Up to 5 years
Median Recurrence Free Survival Following Pancreaticoduodenectomy
The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
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
Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time frame: Up to 7 years
Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
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). Cancer 2012;118:1382-90
Time frame: Up to 7 years
CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Biochemical response is a decrease of \>= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
Time frame: Up to 26 weeks after surgery
Surgical Completion Rate and Complication Rate
Time frame: Up to 6 weeks following the completion of chemoradiotherapy
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)
Percent of Patients Surviving at Annual Intervals
Time frame: 5 years
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