Back to resultsStereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer
Eligibility Criteria
Inclusion Criteria:
- Patient age >= 18 years
- Performance status of 0-3
- Unresectable pancreatic cancer
- Maximum tumor diameter < 7.5 cm
- Signed study-specific consent form
Exclusion Criteria:
- Maximum tumor diameter > 7.5 cm
- Prior radiotherapy to the upper abdomen
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Sites / Locations
- St. John's Mercy Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Stereotactic Radiation to Pancreas
Outcomes
Primary Outcome Measures
Local Control Rate
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.
Secondary Outcome Measures
Late Toxicity Rate
Toxicities will be graded using CTCAE criteria at specified timepoints.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01346410
Brief Title
Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
Official Title
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.
Detailed Description
This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Stereotactic Radiation to Pancreas
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Local Control Rate
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
Secondary Outcome Measure Information:
Title
Late Toxicity Rate
Description
Toxicities will be graded using CTCAE criteria at specified timepoints.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient age >= 18 years
Performance status of 0-3
Unresectable pancreatic cancer
Maximum tumor diameter < 7.5 cm
Signed study-specific consent form
Exclusion Criteria:
Maximum tumor diameter > 7.5 cm
Prior radiotherapy to the upper abdomen
Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Facility Information:
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
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