A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median overall survival of patients with adenocarcinoma of the pancreas
Estimated by the Kaplan Meier method.
From the date of registration to date of death due to any cause, assessed up to 22 months
No
Andrew Coveler
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6511
NCT00609336
January 2008
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |