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Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01346410
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kathy Baglan, MD, Mercy Research

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Radiation: Stereotactic Body Radiotherapy

  Participant Flow

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
Stereotactic Radiation to Pancreas

Stereotactic Radiation to Pancreas

Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)


Participant Flow:   Overall Study
    Stereotactic Radiation to Pancreas
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Stereotactic Radiation to Pancreas

Stereotactic Radiation to Pancreas

Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)


Baseline Measures
   Stereotactic Radiation to Pancreas 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Years]
Mean (Full Range)
 79 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 


  Outcome Measures

1.  Primary:   Local Control Rate   [ Time Frame: 5 years ]

2.  Secondary:   Late Toxicity Rate   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Kathy Baglan
Organization: Mercy
phone: 3144345886
e-mail: kathy.baglan@mercy.net



Responsible Party: Kathy Baglan, MD, Mercy Research
ClinicalTrials.gov Identifier: NCT01346410     History of Changes
Other Study ID Numbers: 08-060
First Submitted: April 29, 2011
First Posted: May 3, 2011
Results First Submitted: January 24, 2018
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018