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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 Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Stereotactic Body Radiotherapy Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
Study Start Date : September 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Stereotactic Radiation to Pancreas
 Radiation: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: 5 years ]
    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 :
  1. Late Toxicity Rate [ Time Frame: 5 years ]
    Toxicities will be graded using CTCAE criteria at specified timepoints.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346410


Locations
United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Mercy Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kathy Baglan, MD, Radiation Oncologist, Mercy Research
ClinicalTrials.gov Identifier: NCT01346410     History of Changes
Other Study ID Numbers: 08-060
First Posted: May 3, 2011    Key Record Dates
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Kathy Baglan, MD, Mercy Research:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases