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Perioperative Therapy for Resectable Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609336
First Posted: February 7, 2008
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew Coveler, University of Washington
Results First Submitted: March 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)

See Detailed Description

gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

gemcitabine: Given IV

oxaliplatin: Given IV


Participant Flow:   Overall Study
    Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
STARTED   35 
Surgery   22 
COMPLETED   22 
NOT COMPLETED   13 
Protocol Violation                3 
Death                1 
LA or Met at Surgery                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients

Reporting Groups
  Description
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)

See Detailed Description

gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 62 
 (46 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  46.9% 
Male      17  53.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      30  93.8% 
Unknown or Not Reported      2   6.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   3.1% 
Asian      1   3.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      30  93.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Overall Survival of Patients With Adenocarcinoma of the Pancreas   [ Time Frame: 5 years ]

2.  Secondary:   Percent of Patients Surviving at 5 Years   [ Time Frame: Up to 5 years ]

3.  Secondary:   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 ]

4.  Secondary:   Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy   [ Time Frame: Up to 7 years ]

5.  Secondary:   Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy   [ Time Frame: Up to 7 years ]

6.  Secondary:   CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy   [ Time Frame: Up to 26 weeks after surgery ]

7.  Secondary:   Surgical Completion Rate and Complication Rate   [ Time Frame: Up to 6 weeks following the completion of chemoradiotherapy ]

8.  Secondary:   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) ]

9.  Secondary:   Percent of Patients Surviving at Annual Intervals   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Coveler, MD
Organization: University of Washington
phone: 206-288-7509
e-mail: acoveler@uw.edu



Responsible Party: Andrew Coveler, University of Washington
ClinicalTrials.gov Identifier: NCT00609336     History of Changes
Other Study ID Numbers: 6511
NCI-2010-00553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6511 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2008
First Posted: February 7, 2008
Results First Submitted: March 21, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017