Perioperative Therapy for Resectable Pancreatic Cancer
|Adenocarcinoma of the Pancreas Stage IA Pancreatic Cancer Stage IB Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: docetaxel Drug: capecitabine Radiation: intensity-modulated radiation therapy Drug: oxaliplatin Procedure: pancreatic surgical procedure Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma|
- Median Overall Survival of Patients With Adenocarcinoma of the Pancreas [ Time Frame: 5 years ]Time at which Kaplan-Meier estimate of overall survival drops below 50%
- Percent of Patients Surviving at 5 Years [ Time Frame: Up to 5 years ]Kaplan-Meier estimate of overall survival at 5 years
- 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 ]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 ]Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
- Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy [ Time Frame: Up to 7 years ]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
- CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy [ Time Frame: Up to 26 weeks after surgery ]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 ]
- 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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2016|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
Drug: gemcitabine hydrochloride
Other Names:Drug: docetaxel
Other Names:Drug: capecitabine
Other Names:Radiation: intensity-modulated radiation therapy
Other Name: IMRTDrug: oxaliplatin
Other Names:Procedure: pancreatic surgical procedure
Other Name: pancreatic surgeryProcedure: therapeutic conventional surgery
Undergo therapeutic conventional surgeryOther: laboratory biomarker analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609336
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Andrew Coveler||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|