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Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01146054
First Posted: June 17, 2010
Last Update Posted: May 15, 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:
Johns Hopkins University
Information provided by (Responsible Party):
Albert Koong, Stanford University
Results First Submitted: January 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Device: CyberKnife based stereotactic radiotherapy
Drug: Gemcitabine
Drug: Fludeoxyglucose (18F) (FDG)

  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
Patients were recruited during new patient clinical visits between 10/22/2009 - 08/14/2013 at Stanford University, Johns Hopkins University and Memorial Sloan-Kettering Cancer Center. Study details were explained by the physician and consent was obtained by the physician or study coordinator according to good clinical practices.

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
SBRT and Gemzar

3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose 18F-positron emission tomography/computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.

Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv


Participant Flow:   Overall Study
    SBRT and Gemzar
STARTED   59 
COMPLETED   49 
NOT COMPLETED   10 
Did not meet dose constraints for SBRT                5 
Rapid tumor progression                2 
Other illness precluded treatment                2 
Lost to Follow-up                1 



  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.
The entire cohort is analyzed.

Reporting Groups
  Description
SBRT and Gemzar

Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.

Device: CyberKnife based stereotactic radiotherapy


Baseline Measures
   SBRT and Gemzar 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      16  32.7% 
>=65 years      33  67.3% 
Age 
[Units: Years]
Median (Full Range)
 67 
 (35 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  36.7% 
Male      31  63.3% 
Region of Enrollment 
[Units: Participants]
 
United States   49 
Baseline Cancer Antigen 19-9 (CA19-9) [1] 
[Units: Participants]
Count of Participants
 
CA 19-9 < 90 U/mL   18 
CA 19-9 >= 90 U/mL   27 
[1] Tumor marker from blood draw during routine labs.
Eastern Cooperative Oncology Group performance status (ECOG PS) [1] 
[Units: Participants]
Count of Participants
 
ECOG 0   21 
ECOG 1   28 
[1]

Performance status assessed by the physician prior to treatment. ECOG 0= Asymptomatic (Fully active, able to carry on all predisease activities without restriction)

ECOG 1 = Symptomatic but completely ambulatory ECOG 2 = Symptomatic, <50% in bed during the day ECOG 3 = Symptomatic, >50% in bed, but not bedbound ECOG 4 = Bedbound, Completely disabled. Cannot carry on any self-care. ECOG 5 = Death

Treating Institutions 
[Units: Participants]
Count of Participants
 
Johns Hopkins University   32 
Memorial Sloan-Kettering Cancer Center   3 
Stanford University   14 


  Outcome Measures
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1.  Primary:   To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.   [ Time Frame: 12/31/2012 ]

2.  Secondary:   Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.   [ Time Frame: 12/31/2012 ]

3.  Secondary:   To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .   [ Time Frame: 12/31/2012 ]

4.  Secondary:   To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.   [ Time Frame: 12/31/2012 ]

5.  Secondary:   Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.   [ Time Frame: 12/31/2012 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Albert C. Koong, M.D., Ph.D., Sue and Bob McCollum Professor, Associate Chair of Radiation Onocology
Organization: Stanford University Comprehensive Cancer Center
phone: 650-498-7703
e-mail: akoong@stanford.edu



Responsible Party: Albert Koong, Stanford University
ClinicalTrials.gov Identifier: NCT01146054     History of Changes
Other Study ID Numbers: IRB-17073
SU-02012010-4843 ( Other Identifier: Stanford University )
PANC0007 ( Other Identifier: OnCore )
First Submitted: June 15, 2010
First Posted: June 17, 2010
Results First Submitted: January 10, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017