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Trial record 53 of 1598 for:    Pancreatic Cancer | United States

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
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stereotactic Radiation to Pancreas
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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)

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Stereotactic Radiation to Pancreas
Hide Arm/Group Description

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)

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
79
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Local Control Rate
Hide Description Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stereotactic Radiation to Pancreas
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2.Secondary Outcome
Title Late Toxicity Rate
Hide Description Toxicities will be graded using CTCAE criteria at specified timepoints.
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stereotactic Radiation to Pancreas
Hide Arm/Group Description

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)

All-Cause Mortality
Stereotactic Radiation to Pancreas
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stereotactic Radiation to Pancreas
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stereotactic Radiation to Pancreas
Affected / at Risk (%)
Total   0/1 (0.00%) 
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
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